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

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ClinicalTrials.gov Identifier: NCT05265520
Recruitment Status : Not yet recruiting
First Posted : March 3, 2022
Last Update Posted : July 20, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Valentina Kutyifa, University of Rochester

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).

Condition or disease Intervention/treatment Phase
Right Bundle-Branch Block Heart Failure His-bundle Pacing Cardiac Resynchronization Therapy Procedure: His-CRT implantation Procedure: BIV-CRT implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: His-Bundle Corrective Pacing in Heart Failure
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : July 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: His-CRT implantation
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.
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.

Active Comparator: BIV-CRT implantation
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.
Procedure: 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.




Primary Outcome Measures :
  1. 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) [ Time Frame: 6 month ]
    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.


Secondary Outcome Measures :
  1. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers [ Time Frame: 6 months ]
    Secondary endpoint measured on a continuous scale of paced ventricular depolarization (QRS) duration in the His-CRT vs. BIV-CRT arm

  2. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV) [ Time Frame: 6 months ]
    Secondary endpoint measured from echocardiography on left ventricular end-systolic volume (LVESV) in the His-CRT vs. BIV-CRT arm

  3. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV) [ Time Frame: 6 months ]
    Secondary endpoint measured from echocardiography on left ventricular end-diastolic volume (LVEDV) in the His-CRT vs. BIV-CRT arm

  4. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP [ Time Frame: 6 months ]
    Secondary endpoint of NT-proBNP in the His-CRT vs. BIV-CRT arm


Other Outcome Measures:
  1. Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months. [ Time Frame: Up to 24 months ]
    Assessing changes in QRS duration at 6, 12, 24 months in the His-CRT vs. BIV-CRT arm

  2. Heart failure (HF) or death events [ Time Frame: Up to 24 months ]
    Assess heart Failure (HF)/death rates in the His-CRT vs. BIV-CRT arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05265520


Contacts
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Contact: Ann Colasurdo 585-275-1054 ann.colasurdo@heart.rochester.edu
Contact: Mary Brown 585-273-5283 mary.brown@heart.rochester.edu

Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Valentina Kutyifa, MD, PhD University of Rochester
Principal Investigator: Roderick Tung, MD University of Arizona
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Responsible Party: Valentina Kutyifa, Associate Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT05265520    
Other Study ID Numbers: STUDY 00007025
1R01HL153390-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes