Clinical trial NCT05265520: His-Bundle Corrective Pacing in Heart Failure
Official title: His-Bundle Corrective Pacing in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Right Bundle-Branch Block
Heart Failure
His-bundle Pacing
Cardiac Resynchronization Therapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-03-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)
timeFrame: 6 month
Secondary outcomes:
measure: Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers
timeFrame: 6 months
measure: Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)
timeFrame: 6 months
measure: Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)
timeFrame: 6 months
measure: Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP
timeFrame: 6 months
Other outcomes:
measure: Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.
timeFrame: Up to 24 months
measure: Heart failure (HF) or death events
timeFrame: Up to 24 months
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Paramus
country: United States
facility: Valley Health System
state: New Jersey
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Rochester
name: Valentina Kutyifa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Roderick Tung, MD
role: PRINCIPAL_INVESTIGATOR
References: