Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05265520
Other study ID # STUDY 00007025
Secondary ID 1R01HL153390-01A
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy