xml: <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/NCT05996562</url>
    </required_header>
    <id_info>
      <org_study_id>Pulnovo-CO-2023-01</org_study_id>
      <nct_id>NCT05996562</nct_id>
    </id_info>
    <brief_title>Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure</brief_title>
    <official_title>Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pulnovo Medical (Wuxi) Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pulnovo Medical (Wuxi) Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery&#xD;
        denervation (PADN) in combined post- and pre- capillary pulmonary hypertension (CpcPH)&#xD;
        associated with chronic heart failure(CHF).&#xD;
  &#xD;
        Participants who have received guideline-directed medical therapy (GDMT) according to 2022&#xD;
        AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1&#xD;
        month, will be treated with PADN and followed for 1 year.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>6-minute walk distance (6MWD) difference</measure>
      <time_frame>6 months</time_frame>
      <description>The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Pulmonary Hypertension</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Pulmonary Artery Denervation (PADN)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pulmonary Artery Denervation</intervention_name>
      <description>Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA.&#xD;
  The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.</description>
      <arm_group_label>Pulmonary Artery Denervation (PADN)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18, ≤75 years;&#xD;
  &#xD;
            2. CpcPH must be confirmed by RHC, defined as:&#xD;
  &#xD;
                 1. Mean pulmonary arterial pressure (mPAP) &gt; 20mmHg;&#xD;
  &#xD;
                 2. Pulmonary capillary wedge pressure (PCWP) &gt; 15mmHg;&#xD;
  &#xD;
                 3. Pulmonary vascular resistance (PVR) &gt; 2WU;&#xD;
  &#xD;
            3. Chronic heart failure has been diagnosed at least 3 months before screening and have&#xD;
               been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at&#xD;
               least 1 month;&#xD;
  &#xD;
            4. Clinically stable HF for at least 1 month, defined as:&#xD;
  &#xD;
                 1. No need of intravenous diuretics, inotropes or vasodilators, and&#xD;
  &#xD;
                 2. Systolic blood pressure (SBP) ≥ 100 and &lt; 160 mmHg, and&#xD;
  &#xD;
                 3. Resting heart rate (HR) ≥ 50 bpm and &lt;100 bpm (&lt;110 bpm in presence of atrial&#xD;
                    fibrillation) on the day of the procedure.&#xD;
  &#xD;
            5. NYHA class II-IVa;&#xD;
  &#xD;
            6. 6MWD ≥ 100 m and ≤ 450 m;&#xD;
  &#xD;
            7. NT-proBNP &gt; 125pg/mL (or BNP &gt; 35pg/mL);&#xD;
  &#xD;
            8. Understand and be willing to sign informed consent and be strictly willing to follow&#xD;
               the protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any of the following:&#xD;
  &#xD;
                 1. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction&#xD;
                    and/or mitral valvular systolic anterior motion (SAM); or&#xD;
  &#xD;
                 2. Pericardial disease; or&#xD;
  &#xD;
                 3. Infiltrative or inflammatory myocardial disease; or&#xD;
  &#xD;
                 4. Valvular heart disease with stenosis or with severe regurgitation; or&#xD;
  &#xD;
                 5. Active endocarditis; or&#xD;
  &#xD;
                 6. Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to&#xD;
                    randomization; or&#xD;
  &#xD;
                 7. Congenital heart disease; or&#xD;
  &#xD;
                 8. Having received any revascularization, including coronary artery bypass grafting&#xD;
                    (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to&#xD;
                    randomization; or anticipated to undergo coronary revascularization (CABG or PCI)&#xD;
                    within 6 months; or&#xD;
  &#xD;
                 9. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber&#xD;
                    pacemakers, have been implanted or are anticipated to be implanted within 6&#xD;
                    months; or&#xD;
  &#xD;
                10. Anticipated to undergo ablation of atrial fibrillation within 6 months; or&#xD;
  &#xD;
                11. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty)&#xD;
                    within 6 months; or&#xD;
  &#xD;
                12. Listing for heart/heart-lung transplantation or anticipated to implant a&#xD;
                    ventricular assist device (VAD)&#xD;
  &#xD;
            2. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to&#xD;
               randomization;&#xD;
  &#xD;
            3. Anticipated to undergo any surgery within the next 6 months;&#xD;
  &#xD;
            4. Cardiac index (CI) measured by RHC &lt; 1.5L/min/m2;&#xD;
  &#xD;
            5. Severe renal insufficiency (eGFR &lt; 30mL/min/1.73m2 by MDRD formula);&#xD;
  &#xD;
            6. Severe liver insufficiency (Child-Pugh classification B-C);&#xD;
  &#xD;
            7. Platelet count &lt; 50 × 109/L;&#xD;
  &#xD;
            8. Life expectancy &lt; 1 year;&#xD;
  &#xD;
            9. Systemic inflammation or other disease requiring long-term use of glucocorticoids or&#xD;
               immunosuppressants;&#xD;
  &#xD;
           10. Active infection requiring oral or intravenous antibiotics;&#xD;
  &#xD;
           11. Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;&#xD;
  &#xD;
           12. Body mass index (BMI) &gt; 40 kg/m²;&#xD;
  &#xD;
           13. Pregnant or lactating women, or planning to be pregnant within one year;&#xD;
  &#xD;
           14. Participation in other clinical trials within 3 months prior to signing the informed&#xD;
               consent;&#xD;
  &#xD;
           15. Any other circumstances that investigators deemed inappropriate to participate in this&#xD;
               trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulmonary Artery Denervation</keyword>
    <keyword>PADN</keyword>
    <keyword>Pulmonary Hypertension</keyword>
    <keyword>Heart Failure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996562
  org study id: Pulnovo-CO-2023-01
  nct id: NCT05996562
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery
        denervation (PADN) in combined post- and pre- capillary pulmonary hypertension (CpcPH)
        associated with chronic heart failure(CHF).
  
        Participants who have received guideline-directed medical therapy (GDMT) according to 2022
        AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1
        month, will be treated with PADN and followed for 1 year.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 6-minute walk distance (6MWD) difference
  time frame: 6 months
  description: The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.
  arm group label: Pulmonary Artery Denervation (PADN)
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Pulmonary Artery Denervation
  description: Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA.
  The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.
  arm group label: Pulmonary Artery Denervation (PADN)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Hypertension, Pulmonary
  mesh term: Hypertension
  mesh term: Heart Failure