Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study

Not Applicable

Terminated

• Conditions: Bradyarrhythmia
• Interventions: Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing; Device: Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing

• Registration Number: NCT01535404
• Lead Sponsor: Haran Burri, MD

Brief Summary

The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (\>= 45%).

Detailed Description

It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Status Verified: 2014-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
• Anticipated >=50% daily ventricular pacing
• LVEF >=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
• Minimum age of 18 years, and at least 1 year life expectancy

Exclusion Criteria

• Prior tricuspid valve replacement (annuloplasty is permitted)
• Intrinsic rhythm < 30bpm
• Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
• Echocardiographic window of insufficient quality for measuring LVEF
• Life expectancy of < 1year
• Pregnancy (women of childbearing potential will undergo pregnancy testing)
• Unable of unwilling to sign a patient informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right ventricular apex pacing	Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing	-
Left ventricular apex pacing	Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing	-

Primary Outcome Measures

Name	Time	Method
Reduction in LVEF	baseline to one year

Secondary Outcome Measures

Name	Time	Method
Incidence of device-related complications	one year
Change in left ventricular end-systolic and end-diastolic volumes	one year
Dyssynchrony evaluation during RV and LV pacing	one year
Change in tricuspid regurgitation severity, if any	one year
Change in mitral regurgitation severity, if any	one year
Success rate of autocapture algorithm for left-and right-ventricular pacing	one year
Mortality and all cause hospitalization	one year
Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy)	one year

Trial Locations

Locations (6)

Cardiovascular Research Institute, University of Maastricht; 🇳🇱 Maastricht, Netherlands

Cardiocentro Ticino (Lugano); 🇨🇭 Lugano, TI, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzern, LU, Switzerland

Kantonsspital St-Gallen; 🇨🇭 St-Gallen, SG, Switzerland

University Hospital of Basel; 🇨🇭 Basel, BS, Switzerland

University Hospital Geneva; 🇨🇭 Geneva, GE, Switzerland