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His-Bundle Corrective Pacing in Heart Failure

RECRUITINGN/ASponsored by University of Rochester
Actively Recruiting
PhaseN/A
SponsorUniversity of Rochester
Started2022-12-02
Est. completion2027-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations14 sites
View on ClinicalTrials.gov →

NCT05265520

Summary

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age 18 years or older (no upper age limit)
* Optimal medical therapy for heart failure by current guidelines
* Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:

  * 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
  * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)

Exclusion Criteria:

* 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
* Pregnancy or planned pregnancy during duration of the study
* On heart transplant list or likely to undergo heart transplant

Conditions5

Cardiac Resynchronization TherapyHeart DiseaseHeart FailureHis Bundle PacingRight Bundle-Branch Block

Locations14 sites

University of Arizona
Phoenix, Arizona, 85006
Mathew Freeman
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kelsey Duggin
University of South Florida
Tampa, Florida, 33606
Jacky He
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Madison Stat
Rush University Medical Center
Chicago, Illinois, 60612
Samreen Ahmed

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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