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RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome

NCT01477138 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2011-11-22

No results posted yet for this study

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)

Conditions

  • Sick Sinus Syndrome

Interventions

PROCEDURE

pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)

Indication for pacemaker implantation: sick sinus syndrome in conformity with the current guidelines. Only market-released CE certified 2-chamber cardiac pacemakers and electrodes are used. The implantation is done according to the applicable standards. Active RV-lead is positioned on the right ventricular septum.

Sponsors & Collaborators

  • Klinikum Nürnberg

    lead OTHER

Principal Investigators

  • Matthias Pauschinger, Prof.Dr.med. · Klinikum Nuernberg South/ Cardiology

  • Dirk Bastian, MD · Klinikum Nuernberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-07-31
Completion
2013-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477138 on ClinicalTrials.gov