RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome

NCT01477138 | Unknown DMC

• 1 other identifier: VOTEPM
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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)

Conditions

Sick Sinus Syndrome

Keywords

Sick Sinus Syndrome; Cardiac Pacing, Artificial; Cardiac Resynchronization Therapy; Pacemaker, Artificial; SSS

Outcome Measures

Primary Outcomes (2)

• end-systolic LV volume

  at randomisation and after 12 months

• left ventricular ejection fraction (LV-EF)

  TTE, Simpson, biplane

  at randomisation and after 12 months

Secondary Outcomes (7)

• TAPSE

  at randomisation and after 12 months

• echocardiographic parameter of dyssynchrony

  at randomisation and after 12 months

• peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope

  at randomisation and after 12 months

• quality of life-scores

  at randomisation and after 12 months

• AF burden

  at randomisation and after 12 months

Study Arms (2)

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)

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)

Interventions

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

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.

Also known as: AAI(R)<=>DDD(R), DDD(R)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with symptomathic sick sinus syndrome

You may qualify if:

• Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Nürnberg: lead

Study Sites (1)

Klinikum Nuernberg South

Nuremberg, Bavaria, 90471, Germany

RECRUITING

Related Publications (10)

• Schwaab B, Frohlig 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. doi: 10.1016/s0735-1097(98)00562-2.

  PMID: 9973009 BACKGROUND

• 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. doi: 10.1016/s0735-1097(02)02169-1.

  PMID: 12392836 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.

  PMID: 12782566 BACKGROUND

• 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. doi: 10.1001/jama.288.24.3115.

  PMID: 12495391 BACKGROUND

• 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. doi: 10.1046/j.1540-8167.2003.03216.x.

  PMID: 14678131 BACKGROUND

• 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. doi: 10.1016/s0002-9149(96)00718-7.

  PMID: 9193029 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.1998.tb00095.x.

  PMID: 9558684 BACKGROUND

• Alboni P, Scarfo S, Fuca 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.

  PMID: 9561877 BACKGROUND

• 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.

  PMID: 19915220 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Pauschinger, Prof.Dr.med.

  Klinikum Nuernberg South/ Cardiology

  STUDY CHAIR

• Dirk Bastian, MD

  Klinikum Nuernberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Bastian, Dr.med

CONTACT

+499113982989; dirk.bastian@klinikum-nuernberg.de

Natalia Rohr

CONTACT

natalia.rohr@klinikum-nuernberg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Natalia Rohr

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: November 22, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

DE (1)