His-Bundle Corrective Pacing in Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
Eligibility criteria
Qualifiers
Age 18 years or older (no upper age limit)
Optimal medical therapy for heart failure by current guidelines
New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
Disqualifiers
Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
Unable or unwilling to follow study protocol
Less than 12 months life expectancy at consent
Trial design
Treatments tested in this trial
- His-CRT implantation
- BIV-CRT implantation
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
14Arizona
University of Arizona85006, Phoenix United States
California
Cedars-Sinai Medical Center90048, Los Angeles United States
Florida
University of South Florida33606, Tampa United States
Illinois
Northwestern Memorial Hospital60611, Chicago United States
Sponsors and collaborators
University of Rochester
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov