RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome (VOTE)
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ClinicalTrials.gov Identifier: NCT01477138 |
Recruitment Status
: Unknown
Verified November 2011 by Natalia Rohr, Klinikum Nürnberg.
Recruitment status was: Recruiting
First Posted
: November 22, 2011
Last Update Posted
: November 22, 2011
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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
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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)
Condition or disease | Intervention/treatment |
---|---|
Sick Sinus Syndrome | Procedure: pacemaker implantation, AAI(R)-DDD(R) versus DDD(R) |

Study Type : | Observational |
Estimated Enrollment : | 126 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Comparison of Right Ventricular Septal Pacing to Minimized Right Ventricular Septal Stimulation in Patients With Sick Sinus Syndrome |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | July 2013 |
Estimated Study Completion Date : | December 2013 |

Group/Cohort | Intervention/treatment |
---|---|
DDD(R)
SSS. PM programmed to DDD(R) mode with ventricular pacing on the right ventricular septum.
|
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.
Other Names:
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AAI(R)<=>DDD(R)
SSS, PM-mode programmed for minimizing right ventricular pacing on the right interventricular septum
|
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.
Other Names:
|
- end-systolic LV volume [ Time Frame: at randomisation and after 12 months ]
- left ventricular ejection fraction (LV-EF) [ Time Frame: at randomisation and after 12 months ]TTE, Simpson, biplane
- TAPSE [ Time Frame: at randomisation and after 12 months ]
- echocardiographic parameter of dyssynchrony [ Time Frame: at randomisation and after 12 months ]TTE, SPWMD, LV-PEP, IVMD
- peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope [ Time Frame: at randomisation and after 12 months ]CPX: cardiopulmonary exercice testing
- quality of life-scores [ Time Frame: at randomisation and after 12 months ]SF-36
- AF burden [ Time Frame: at randomisation and after 12 months ]
- % ventricular pacing [ Time Frame: at randomisation and after 12 months ]
- LV end diastolic volume [ Time Frame: at randomisation and after 12 months ]TTE

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477138
Contact: Dirk Bastian, Dr.med | +499113982989 | dirk.bastian@klinikum-nuernberg.de | |
Contact: Natalia Rohr | natalia.rohr@klinikum-nuernberg.de |
Germany | |
Klinikum Nuernberg South | Recruiting |
Nuernberg, Bavaria, Germany, 90471 | |
Contact: Bastian dirk.bastian@klinikum-nuernberg.de | |
Principal Investigator: Natalia Rohr | |
Sub-Investigator: Wolfgang Kirste, MD |
Study Chair: | Matthias Pauschinger, Prof.Dr.med. | Klinikum Nuernberg South/ Cardiology | |
Principal Investigator: | Dirk Bastian, MD | Klinikum Nuernberg |
Publications of Results:
Other Publications:
Responsible Party: | Natalia Rohr, Klinikum Nürnberg |
ClinicalTrials.gov Identifier: | NCT01477138 History of Changes |
Other Study ID Numbers: |
VOTEPM |
First Posted: | November 22, 2011 Key Record Dates |
Last Update Posted: | November 22, 2011 |
Last Verified: | November 2011 |
Keywords provided by Natalia Rohr, Klinikum Nürnberg:
Sick Sinus Syndrome Cardiac Pacing, Artificial Cardiac Resynchronization Therapy Pacemaker, Artificial SSS |
Additional relevant MeSH terms:
Syndrome Sick Sinus Syndrome Disease Pathologic Processes Arrhythmia, Sinus |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Heart Block |