<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260244</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10159</org_study_id>
    <nct_id>NCT03260244</nct_id>
  </id_info>
  <brief_title>EnSite Precision Observational Study</brief_title>
  <official_title>A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This document is a clinical investigation plan (CIP) for the EnSite Precision Observational&#xD;
      Study.&#xD;
&#xD;
      This clinical study is intended to quantify and characterize the usage of the EnSite&#xD;
      Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world&#xD;
      environment. This study will be conducted in patients who are indicated for a cardiac&#xD;
      electrophysiological (EP) mapping and radio frequency ablation procedure using a&#xD;
      three-dimensional system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces&#xD;
      features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration,&#xD;
      lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the&#xD;
      success of complex ablation procedures. Utilization of this system in the treatment of&#xD;
      complex ablation procedures and its impact on patient outcomes is not well characterized.&#xD;
      This clinical study is designed to collect a broad range of usage scenarios, therefore this&#xD;
      clinical study has limited patient selection criteria and data collection is focused on&#xD;
      EnSite Precision™ Cardiac Mapping System usage and patient outcomes.&#xD;
&#xD;
      The data collected from the procedure (performed per Instructions For Use (IFU) and per&#xD;
      standard practice of the physician) as well as the 12 month follow up period enables the&#xD;
      Sponsor to review the system's standard practice usage. This information will be added to the&#xD;
      current knowledge and understanding of treatment options for patients with arrhythmias, which&#xD;
      can assist the Sponsor to provide future recommendations for best practices to improve&#xD;
      patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Summary of subjects that used EnSite™ AutoMap and AutoMark module</measure>
    <time_frame>during procedure</time_frame>
    <description>Overall usage of EnSite™ AutoMap Module. This will be summarized by the number and proportion of subjects with a procedure that use EnSite™ AutoMap. Overall usage of AutoMark module. This will be summarized by the number and proportion of subjects with a procedure that use AutoMark.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of EnSite™ Automap and AutoMark Module software settings used per arrhythmia</measure>
    <time_frame>during procedure</time_frame>
    <description>Among the subjects with EnSite™ AutoMap and AutoMark module features used during the procedure, the settings of EnSite™ AutoMap and AutoMark features will be summarized descriptively by each arrhythmia, as number and proportion or mean and standard deviation as appropriate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mapping time associated with (re-)mapping one or multiple arrhythmias per catheter type used in a single subject</measure>
    <time_frame>during procedure</time_frame>
    <description>Mapping time will be summarized (e.g. as mean, median, standard deviation, minimum and maximum) across arrhythmia types and for each type of arrhythmia per catheter, as appropriate for the different map types.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Used Points per Minute per catheter type stratified by arrhythmia type and mapping type</measure>
    <time_frame>during procedure</time_frame>
    <description>Mapping points per minute used will be summarized (e.g. as mean, median, standard deviation, minimum and/or maximum) across arrhythmia types and for each type of arrhythmia per catheter as appropriate, for the different map types</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of acute success based on pre-defined procedural endpoints</measure>
    <time_frame>during procedure</time_frame>
    <description>The number and proportion of subjects with acute success will be summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from arrhythmia recurrence</measure>
    <time_frame>From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months</time_frame>
    <description>This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of repeat ablations up to 12 months.</measure>
    <time_frame>1 year</time_frame>
    <description>This will be summarized as the total count of repeat ablations up to 12 months and the total number of subjects who experience at least one repeat ablation up to 12 months among all subjects in analysis population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of NavX Patch placement locations used</measure>
    <time_frame>during procedure</time_frame>
    <description>The number and proportion of subjects with NavX patches (Surface Electrode Patches) placed by location</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of gaps in lesions identified during the procedure that require touch-up ablation</measure>
    <time_frame>during procedure</time_frame>
    <description>The number and proportion of subjects with gaps in lesions identified will be summarized and reported. The summary of number of gaps identified will be reported. The number and proportion of subjects where the AutoMark Module assisted in identifying these gaps will be summarized and reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in EQ-5D quality of life score at 6 and 12 months</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in EQ-5D at 6 months from baseline, and changes in EQ-5D score at 12 months from baseline will be summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of unscheduled visits and hospitalizations due to arrhythmia</measure>
    <time_frame>1 year</time_frame>
    <description>The number of unscheduled visits due to arrhythmia, or hospitalizations due to arrhythmia will be summarized per subject and presented as the number of subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall procedure time</measure>
    <time_frame>during procedure</time_frame>
    <description>Overall procedure time for the index procedure will be summarized e.g. as mean, standard deviation, minimum and/or maximum. Procedure time will be derived as (Procedure stop time (Last catheter out) - Procedure start time (first catheter in)).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall system stability</measure>
    <time_frame>during procedure</time_frame>
    <description>Proportion of subjects with the system stable throughout the procedure. System stability will be based on the opinion of the investigator.</description>
  </primary_outcome>
  <enrollment type="Actual">1065</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac mapping and radiofrequency ablation procedure</intervention_name>
    <description>It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome.&#xD;
Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The intended population for this clinical study is patients over the age of 18 years who&#xD;
        are eligible for a cardiac EP mapping and RF ablation procedure using the EnSite Precision™&#xD;
        Cardiac Mapping System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indicated for a cardiac EP mapping and RF ablation procedure using a 3D mapping system&#xD;
             per IFU&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Able to provide informed consent for study participation and willing and able to&#xD;
             comply with the protocol described evaluations and follow up schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are only presenting with:&#xD;
&#xD;
               -  Atrioventricular Nodal Reentrant Tachycardia (AVNRT)&#xD;
&#xD;
               -  Atrioventricular Reentrant Tachycardia (AVRT)&#xD;
&#xD;
          -  Planned cryoablation procedure&#xD;
&#xD;
          -  Implanted with a neurostimulator&#xD;
&#xD;
          -  Contraindication to anticoagulation&#xD;
&#xD;
          -  Known presence of cardiac thrombus&#xD;
&#xD;
          -  Recent (&lt;3 months) myocardial infarction or unstable angina or coronary artery by-pass&#xD;
&#xD;
          -  Currently enrolled in a clinical study/investigation evaluating another device or drug&#xD;
             that would confound the results of this study&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Individuals whose willingness to volunteer in a study, in the judgement of&#xD;
             investigator or public authorities, could be unduly influenced by lack of or loss of&#xD;
             the autonomy due to immaturity, or mental disability, or adverse personal&#xD;
             circumstances, or hierarchical influence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Ruffner, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Medical Center Princeton</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of North East Arkansas</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Cardiology</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda Memorial Hospital</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryan LGH Medical Center East</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Medical Group</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>atrial flutter</keyword>
  <keyword>supraventricular tachycardia</keyword>
  <keyword>ventricular tachycardia</keyword>
  <keyword>premature ventricular contractions</keyword>
  <keyword>cardiac mapping system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260244
org study id: SJM-CIP-10159
nct id: NCT03260244
lead sponsor: 
has dmc: No
is fda regulated drug: No
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational
      Study.

      This clinical study is intended to quantify and characterize the usage of the EnSite
      Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world
      environment. This study will be conducted in patients who are indicated for a cardiac
      electrophysiological (EP) mapping and radio frequency ablation procedure using a
      three-dimensional system.
The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces
      features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration,
      lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the
      success of complex ablation procedures. Utilization of this system in the treatment of
      complex ablation procedures and its impact on patient outcomes is not well characterized.
      This clinical study is designed to collect a broad range of usage scenarios, therefore this
      clinical study has limited patient selection criteria and data collection is focused on
      EnSite Precision™ Cardiac Mapping System usage and patient outcomes.

      The data collected from the procedure (performed per Instructions For Use (IFU) and per
      standard practice of the physician) as well as the 12 month follow up period enables the
      Sponsor to review the system's standard practice usage. This information will be added to the
      current knowledge and understanding of treatment options for patients with arrhythmias, which
      can assist the Sponsor to provide future recommendations for best practices to improve
      patient outcomes.
observational model: Cohort
time perspective: Prospective
measure: Summary of subjects that used EnSite™ AutoMap and AutoMark module
time frame: during procedure
description: Overall usage of EnSite™ AutoMap Module. This will be summarized by the number and proportion of subjects with a procedure that use EnSite™ AutoMap. Overall usage of AutoMark module. This will be summarized by the number and proportion of subjects with a procedure that use AutoMark.
measure: Summary of EnSite™ Automap and AutoMark Module software settings used per arrhythmia
time frame: during procedure
description: Among the subjects with EnSite™ AutoMap and AutoMark module features used during the procedure, the settings of EnSite™ AutoMap and AutoMark features will be summarized descriptively by each arrhythmia, as number and proportion or mean and standard deviation as appropriate.
measure: Mapping time associated with (re-)mapping one or multiple arrhythmias per catheter type used in a single subject
time frame: during procedure
description: Mapping time will be summarized (e.g. as mean, median, standard deviation, minimum and maximum) across arrhythmia types and for each type of arrhythmia per catheter, as appropriate for the different map types.
measure: Used Points per Minute per catheter type stratified by arrhythmia type and mapping type
time frame: during procedure
description: Mapping points per minute used will be summarized (e.g. as mean, median, standard deviation, minimum and/or maximum) across arrhythmia types and for each type of arrhythmia per catheter as appropriate, for the different map types
measure: Rate of acute success based on pre-defined procedural endpoints
time frame: during procedure
description: The number and proportion of subjects with acute success will be summarized.
measure: Freedom from arrhythmia recurrence
time frame: From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months
description: This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.
measure: Number of repeat ablations up to 12 months.
time frame: 1 year
description: This will be summarized as the total count of repeat ablations up to 12 months and the total number of subjects who experience at least one repeat ablation up to 12 months among all subjects in analysis population.
measure: Summary of NavX Patch placement locations used
time frame: during procedure
description: The number and proportion of subjects with NavX patches (Surface Electrode Patches) placed by location
measure: Number of gaps in lesions identified during the procedure that require touch-up ablation
time frame: during procedure
description: The number and proportion of subjects with gaps in lesions identified will be summarized and reported. The summary of number of gaps identified will be reported. The number and proportion of subjects where the AutoMark Module assisted in identifying these gaps will be summarized and reported.
measure: Changes in EQ-5D quality of life score at 6 and 12 months
time frame: 1 year
description: Changes in EQ-5D at 6 months from baseline, and changes in EQ-5D score at 12 months from baseline will be summarized.
measure: Number of unscheduled visits and hospitalizations due to arrhythmia
time frame: 1 year
description: The number of unscheduled visits due to arrhythmia, or hospitalizations due to arrhythmia will be summarized per subject and presented as the number of subjects
measure: Overall procedure time
time frame: during procedure
description: Overall procedure time for the index procedure will be summarized e.g. as mean, standard deviation, minimum and/or maximum. Procedure time will be derived as (Procedure stop time (Last catheter out) - Procedure start time (first catheter in)).
measure: Overall system stability
time frame: during procedure
description: Proportion of subjects with the system stable throughout the procedure. System stability will be based on the opinion of the investigator.
intervention type: Procedure
intervention name: cardiac mapping and radiofrequency ablation procedure
description: It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome.
Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristin Ruffner, PhD
role: Study Director
affiliation: Abbott
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No