His Bundle Pacing Versus Right Ventricular Pacing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)

Conditions
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Pacing-Induced Cardiomyopathy

Intervention / Treatment
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* Device: His bundle pacing
* Device: Right ventricular pacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover double-blind
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: His bundle pacing<br>Pacing programmed from the His bundle lead | Device: His bundle pacing<br>* Pacing with capture of the His bundle<br>|
| Placebo Comparator: Right ventricular pacing<br>Pacing programmed from the right ventricular lead | Device: Right ventricular pacing<br>* Pacing from the right ventricular lead (septal or apical)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | Assessed by gated Equilibrium Radionuclide Angiography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular peak filling rate (EDV/s) | Assessed by gated Equilibrium Radionuclide Angiography | 6 months | 
| NYHA functional class | Investigator evaluation | 6 months | 
| 6-minute walk test | Investigator evaluation | 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) | 6 months | 
| Right ventricular ejection fraction | Assessed by gated Equilibrium Radionuclide Angiography | 6 months | 
| Hospital admission for cardiovascular causes | Number of days of admissions for cardiovascular causes | 6 months | 
| Hospital admission for cardiovascular causes | Duration in days of admissions for cardiovascular causes | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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His bundle pacing, Right ventricular pacing, Left ventricular systolic function