Sick Sinus Syndrome Clinical Trial
Official title:
Comparison of Right Ventricular Septal Pacing to Minimized Right Ventricular Septal Stimulation in Patients With Sick Sinus Syndrome
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)
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)
;
Observational Model: Case Control, Time Perspective: Prospective
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