His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Geneva
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Left ventricular ejection fraction
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Left ventricular ejection fraction
Time Frame: 6 months
Assessed by gated Equilibrium Radionuclide Angiography
Secondary Outcomes
- Hospital admission for cardiovascular causes(up to 6 months)
- Left ventricular peak filling rate (EDV/s)(6 months)
- NYHA functional class(6 months)
- 6-minute walk test(6 months)
- Quality of life measure by SF-36 questionnaire(6 months)
- Right ventricular ejection fraction(6 months)
Investigators
Haran Burri, MD
Professor
University Hospital, Geneva