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Clinical Trial Summary

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)


Clinical Trial Description

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) ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01477138
Study type Observational
Source Klinikum Nürnberg
Contact Dirk Bastian, Dr.med
Phone +499113982989
Email dirk.bastian@klinikum-nuernberg.de
Status Recruiting
Phase N/A
Start date July 2011
Completion date December 2013

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