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

Sponsor:

Information provided by (Responsible Party):

Natalia Rohr, Klinikum Nürnberg

Study Description

Brief 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)

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

Show Detailed Description

Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Sick sinus syndrome

U.S. FDA Resources

Groups and Cohorts

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: 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)

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:

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)

Other Names:

AAI(R)<=>DDD(R)
DDD(R)

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

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

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 of Results:

Nielsen, Jens Cosedis - Blomstrom-Lundqvist, Carina. DANPACE: The Danish multicenter randomised trial on single lead atrial versus dual chamber pacing in sick sinus syndrome. ESC Kongress 2010, Stockholm, Session number: 708001 - 70800.

Other Publications:

Schwaab B, Fröhlig G, Alexander C, Kindermann M, Hellwig N, Schwerdt H, Kirsch CM, Schieffer H. Influence of right ventricular stimulation site on left ventricular function in atrial synchronous ventricular pacing. J Am Coll Cardiol. 1999 Feb;33(2):317-23.

Tse HF, Yu C, Wong KK, Tsang V, Leung YL, Ho WY, Lau CP. Functional abnormalities in patients with permanent right ventricular pacing: the effect of sites of electrical stimulation. J Am Coll Cardiol. 2002 Oct 16;40(8):1451-8.

Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. Epub 2003 Jun 2.

Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23.

Stambler BS, Ellenbogen K, Zhang X, Porter TR, Xie F, Malik R, Small R, Burke M, Kaplan A, Nair L, Belz M, Fuenzalida C, Gold M, Love C, Sharma A, Silverman R, Sogade F, Van Natta B, Wilkoff BL; ROVA Investigators. Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Nov;14(11):1180-6.

Giudici MC, Thornburg GA, Buck DL, Coyne EP, Walton MC, Paul DL, Sutton J. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol. 1997 Jan 15;79(2):209-12.

de Cock CC, Meyer A, Kamp O, Visser CA. Hemodynamic benefits of right ventricular outflow tract pacing: comparison with right ventricular apex pacing. Pacing Clin Electrophysiol. 1998 Mar;21(3):536-41.

Alboni P, Scarfò S, Fucà G, Mele D, Dinelli M, Paparella N. Short-term hemodynamic effects of DDD pacing from ventricular apex, right ventricular outflow tract and proximal septum. G Ital Cardiol. 1998 Mar;28(3):237-41.

Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, Fang F, Lam KH, Chan HC, Fung JW. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009 Nov 26;361(22):2123-34. doi: 10.1056/NEJMoa0907555. Epub 2009 Nov 15.


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

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