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RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome (VOTE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Klinikum Nürnberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Natalia Rohr, Klinikum Nürnberg
ClinicalTrials.gov Identifier:
NCT01477138
First received: July 5, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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)

Condition Intervention
Sick Sinus Syndrome
Procedure: pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Klinikum Nürnberg:

Primary Outcome Measures:
  • end-systolic LV volume [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
  • left ventricular ejection fraction (LV-EF) [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
    TTE, Simpson, biplane


Secondary Outcome Measures:
  • TAPSE [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
  • echocardiographic parameter of dyssynchrony [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
    TTE, SPWMD, LV-PEP, IVMD

  • peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
    CPX: cardiopulmonary exercice testing

  • quality of life-scores [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
    SF-36

  • AF burden [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
  • % ventricular pacing [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
  • LV end diastolic volume [ Time Frame: at randomisation and after 12 months ] [ Designated as safety issue: No ]
    TTE


Estimated Enrollment: 126
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • AAI(R)<=>DDD(R)
  • DDD(R)
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:
  • AAI(R)<=>DDD(R)
  • DDD(R)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with symptomathic sick sinus syndrome

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477138

Contacts
Contact: Dirk Bastian, Dr.med +499113982989 dirk.bastian@klinikum-nuernberg.de
Contact: Natalia Rohr natalia.rohr@klinikum-nuernberg.de

Locations
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         
Sponsors and Collaborators
Klinikum Nürnberg
Investigators
Study Chair: Matthias Pauschinger, Prof.Dr.med. Klinikum Nuernberg South/ Cardiology
Principal Investigator: Dirk Bastian, MD Klinikum Nuernberg
  More Information

Publications:

Responsible Party: Natalia Rohr, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT01477138     History of Changes
Other Study ID Numbers: VOTEPM
Study First Received: July 5, 2011
Last Updated: November 18, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Nürnberg:
Sick Sinus Syndrome
Cardiac Pacing, Artificial
Cardiac Resynchronization Therapy
Pacemaker, Artificial
SSS

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014