His Bundle Pacing Versus Right Ventricular Pacing

University Hospital, Geneva29 enrolled

Overview

This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)\>40%. The primary outcome measure is LVEF.

Monocentric, randomized, double-blind comparative crossover clinical study. Patients with a standard pacing indication with \>20% ventricular pacing, with a baseline LVEF \>40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pacing-Induced Cardiomyopathy

Interventions

His bundle pacingDEVICE

Pacing with capture of the His bundle

Right ventricular pacingDEVICE

Pacing from the right ventricular lead (septal or apical)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Baseline LVEF\>40% * Standard pacing indication with \>20% VP * Functional His bundle lead with confirmed His capture * Functional right ventricular lead with myocardial capture Exclusion Criteria: * Unable to sign an informed consent form

Locations (1)

University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Outcomes

Primary Outcomes

Left ventricular ejection fraction

Assessed by gated Equilibrium Radionuclide Angiography

Time frame: 6 months

Secondary Outcomes

Left ventricular peak filling rate (EDV/s)

Assessed by gated Equilibrium Radionuclide Angiography

Time frame: 6 months

NYHA functional class

Investigator evaluation

Time frame: 6 months

6-minute walk test

Investigator evaluation

Time frame: 6 months

Quality of life measure by SF-36 questionnaire

SF-36 questionnaire; 0-100 score (the higher the score, the better the quality of life)

Time frame: 6 months

Right ventricular ejection fraction

Assessed by gated Equilibrium Radionuclide Angiography

Time frame: 6 months

Hospital admission for cardiovascular causes

Number of days of admissions for cardiovascular causes

Time frame: 6 months

Hospital admission for cardiovascular causes

Duration in days of admissions for cardiovascular causes

Time frame: up to 6 months

Data from ClinicalTrials.gov

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