His-Bundle Corrective Pacing in Heart Failure (HIS-CRT)

University of Rochester

Status: Enrolling

Conditions: Right Bundle-Branch Block; Cardiac Resynchronization Therapy; Heart Failure; His-bundle Pacing

Treatments: Procedure: His-CRT implantation; Procedure: BIV-CRT implantation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05265520

STUDY 00007025

1R01HL153390-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

His-CRT implantation

Active Comparator group

Description:

His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.

Treatment:

Procedure: His-CRT implantation

BIV-CRT implantation

Active Comparator group

Description:

BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Treatment:

Procedure: BIV-CRT implantation