Heart Failure Clinical Trial

His-Bundle Corrective Pacing in Heart Failure

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).

View Full Description

Full Description

In this prospective, randomized, multi-center clinical 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 Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT05265520

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

University of Chicago
Chicago Illinois, 60637, United States More Info
Shahram Sarrafi
Contact
Valley Health System
Paramus New Jersey, 07652, United States More Info
Kim Michel
Contact
University of Vermont
Burlington Vermont, 05401, United States More Info
Amy Henderson
Contact

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT05265520

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.