Background:~Potential negative effects of pacing in the RV-apex are well documented~Asynchronous ventricular activation~reduction of systolic and diastolic LV function~Experimental data: histological changes~Asymmetric LV hypertrophy and thinning~However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial:~Acute versus chronic~Small number of cases, uncontrolled, unblinded,~Brief periods of observation in the cross-over design (3 months)~RVOT often summarizes different stimulation sites: high RVOT, lateral, septal. Actually only limited data with proven septal stimulation~No objective performance assessment (CPX)~Assessment of alternative stimulation site previously RVOT versus RV-apex,~ventricular pacing compared to ventricular pacing, then tested a potential harm to another~The question of the optimal pacing mode of patients with SSS (DDDR versus AAIR) appears to be open again. While in Germany, two-chamber systems with AAI [R] mode with ventricular back-up are used, should the DDD (R) mode with an AV delay ≤ 220 ms be the preferred pacing mode, according to the results of the DANPACE trial for patients with SSS [DANPACE, ESC 2010, Stockholm].~Aim:~- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS~Inclusion criterion:~-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)~Exclusion criteria:~Life expectancy < 2 years~Age <18 years~Noncompliance with regard to participation in the study~Pregnancy~AV block ° 2 and higher~Permanent atrial fibrillation~Heart failure NYHA III and IV, reduced LV-EF <40%~ICD indication~Acute coronary syndrome. PCI or CABG <3 months~Heart transplant~Placement of septal RV electrode is not possible~Study design:~Prospective, monocentric, randomized, double-blinded~Run-in phase: 4 weeks AAI [R]-DDD [R]~ECG, PM-interrogation, echocardiography, performance diagnostics, CPX, QoL questionnaire~Randomization: two groups 4 weeks (between 3 to 6 weeks) after implant A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].~FU: 6 and 12-months~ECG, Holter-ECG, PM-interrogation, echocardiography, performance diagnostics, CPX, QoL questionnaire~Extension of follow-up if possible~Primary endpoints:~-LV ejection fraction and end-systolic LV volume after 12 months.~Secondary endpoints:~-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.~Blinding:~Patient compared to the pacing mode~Physician: offline analysis of echo and CPX blinded to the pacing mode~Statistics/sample size estimation:~In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:~90% power/alpha 5%: 84 patients per group~80% power/alpha 5%: 63 patients per group~10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.~Material~PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)~pacing leads: market-released standard active electrodes (eg. BSCI FineLine 4470 and 4471) Implantation~Transvenously~RA-electrode: if possible, short atrial conduction time~RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
Background:~Potential negative effects of pacing in the RV-apex are well documented~However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial.~The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial [DANPACE, ESC 2010, Stockholm].~Aim:~- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS~Inclusion criterion:~-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)~Exclusion criteria:~Life expectancy < 2 years~Age <18 years~Noncompliance with regard to participation in the study~Pregnancy~AV block ° 2 and higher~Permanent atrial fibrillation~Heart failure NYHA III and IV, reduced LV-EF <40%~ICD indication~Acute coronary syndrome. PCI or CABG <3 months~Heart transplant~Placement of septal RV electrode is not possible~Study design:~Prospective, monocentric, randomized, double-blinded~Run-in phase: for weeks AAI [R]-DDD [R]~Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].~FU: 6 and 12-months~Primary endpoints:~-LV ejection fraction and end-systolic LV volume after 12 months.~Secondary endpoints:~-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.~Statistics/sample size estimation:~In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:~90% power/alpha 5%: 84 patients per group~80% power/alpha 5%: 63 patients per group~10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.~Material~PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)~pacing leads: market-released standard active electrodes~RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)