Evaluating His-Bundle Pacing for Heart Failure Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) against traditional cardiac resynchronization therapy (BIV-CRT) in patients suffering from heart failure and right bundle branch block (RBBB). The study will assess improvements in left ventricular ejection fraction (LVEF) and various biomarkers over a period of 24 months. Participants will be monitored for changes in their functional status and quality of life, providing insights into the mechanisms of benefit from His-CRT. The trial is designed to be prospective and randomized, involving multiple centers to ensure a diverse patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arizona
  Phoenix, Arizona, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Valentina Kutyifa, MD, PhD — University of Rochester
• Study coordinator: Ann Colasurdo
• Email: ann.colasurdo@heart.rochester.edu
• Phone: 585-275-1054

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Coronary blood flow testing in people with reduced ejection fraction and left bundle branch block after CRT

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.