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

Haran Burri, MD36 enrolled

Overview

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%).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bradyarrhythmia

Interventions

Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacingDEVICE

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead

Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacingDEVICE

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Cardiovascular Research Institute, University of Maastricht

Maastricht, Netherlands

University Hospital of Basel

Basel, Canton of Basel-City, Switzerland

University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Kantonsspital Luzern

Lucerne, Canton of Lucerne, Switzerland

Outcomes

Primary Outcomes

Reduction in LVEF

Time frame: baseline to one year

Secondary Outcomes

Change in left ventricular end-systolic and end-diastolic volumes

Time frame: one year

Dyssynchrony evaluation during RV and LV pacing

Time frame: one year

Change in tricuspid regurgitation severity, if any

Time frame: one year

Change in mitral regurgitation severity, if any

Time frame: one year

Incidence of device-related complications

Time frame: one year

Success rate of autocapture algorithm for left-and right-ventricular pacing

Time frame: one year

Mortality and all cause hospitalization

Time frame: 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)

Time frame: one year

Data from ClinicalTrials.gov

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