His-Bundle Corrective Pacing in Heart Failure

Heart Failure Clinical Trial

— HIS-CRT  

Official title:

His-Bundle Corrective Pacing in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265520
• Other study ID #: STUDY 00007025
• Secondary ID: 1R01HL153390-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: January 2024
• Source: University of Rochester
• Contact: Ann Colasurdo
• Phone: 585-275-1054
• Email: ann.colasurdo[@]heart.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bundle-Branch Block
• Cardiac Resynchronization Therapy
• Heart Failure
• Right Bundle-Branch Block

Intervention

Procedure:
• His-CRT implantation
The pathophysiological process is utilized in His-Bundle corrective pacing, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular endocardial lead.
• BIV-CRT implantation
Biventricular cardiac resynchronization therapy has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont
United States	University of Chicago	Chicago	Illinois
United States	Valley Health System	Paramus	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.	Assessing changes in QRS duration at 6, 12, 24 months in the His-CRT vs. BIV-CRT arm	Up to 24 months
Other	Heart failure (HF) or death events	Assess heart Failure (HF)/death rates in the His-CRT vs. BIV-CRT arm	Up to 24 months
Primary	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)	The effect of His-CRT vs. BIV-CRT on left ventricular ejection fraction (as a percentage) measured during an echocardiography imaging study will be analyzed using an analysis of covariance model for changes in LVEF from pre-implantation (baseline) to post-implantation (6 months follow-up), with randomized treatment group as the factor of interest, and baseline LVEF as a covariate. A t-test will be performed using this model to compare the adjusted group means, and a confidence interval will be constructed for their difference.	6 month
Secondary	Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers	Secondary endpoint measured on a continuous scale of paced ventricular depolarization (QRS) duration in the His-CRT vs. BIV-CRT arm	6 months
Secondary	Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)	Secondary endpoint measured from echocardiography on left ventricular end-systolic volume (LVESV) in the His-CRT vs. BIV-CRT arm	6 months
Secondary	Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)	Secondary endpoint measured from echocardiography on left ventricular end-diastolic volume (LVEDV) in the His-CRT vs. BIV-CRT arm	6 months
Secondary	Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP	Secondary endpoint of NT-proBNP in the His-CRT vs. BIV-CRT arm	6 months