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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05650658
Other study ID # PLACER 2021C3- 24160
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 13, 2023
Est. completion date June 30, 2029

Study information

Verified date November 2023
Source Baylor College of Medicine
Contact Mihail G Chelu, MD, PhD
Phone 7137987291
Email leftvsleft@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.


Description:

In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the comparative effectiveness His or Left bundle branch pacing (His/LBBP) vs. biventricular pacing (BiVP) in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy by assessing all cause death and heart failure hospitalization at the end of the study. Additional formal secondary objectives include evaluation disease-specific quality and psychological adjustment changes at 1 year after device implant and evaluation of a composite of death of any cause or heart failure hospitalization or more >15% increase in the left ventricular end-systolic volume index at the end of the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 2136
Est. completion date June 30, 2029
Est. primary completion date June 30, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men and women 18 years of age or older. - A LVEF = 50% within 6 months prior to enrollment. - Resting QRS duration =130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing >40% OR device in place with right ventricular pacing > 40%. - Are optimized on HF guideline directed medical therapy according to current HF published guidelines. Exclusion Criteria: - Women who are pregnant, lactating, or plan to become pregnant during the course of the trial. - Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months. - Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment. - Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment. - Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis). - Participants with Chagas disease, cardiac sarcoidosis or amyloidosis. - Expected to receive left ventricular assist device or heart transplantation within 6 months. - Participants with severe valvular disease (e.g., aortic stenosis). - Have a life expectancy of less than 12 months. - Participants with irreversible brain damage from preexisting cerebral disease. - Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine. - Participants participating in any other interventional cardiovascular clinical trial. - Participants who would be unable to return for follow-up visits due to the distance from the clinic. - Participants who do not anticipate being a resident of the area for the scheduled duration of the trial.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
His/LBBP
Pacing at the level His-Bundle or left bundle branch is used to correct the underlying conduction abnormality, 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 defibrillator endocardial lead for LVEF=35% and by a right atrial endocardial lead for LVEF 36-50%.
BiVP
Biventricular pacing 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. For LVEF=35% a biventricular pacemaker-defibrillator will be implanted while for LVEF 36-50% a biventricular pacemaker will be implanted.

Locations

Country Name City State
United States Rush University Chicago Illinois
United States University of Chicago Chicago Illinois
United States Virginia Commonwealth University Richmond Virginia
United States Geisinger Commonwealth School of Medicine Scranton Pennsylvania

Sponsors (6)

Lead Sponsor Collaborator
Baylor College of Medicine East Carolina University, Patient-Centered Outcomes Research Institute, Rush University, University of Utah, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Appropriate ICD therapy for ventricular arrhythmias Antitachycardia pacing or ICD shocks 5.5 years
Other Change in NT-proBNP at 12 months Measurement of heart failure serum biomarker NT-proBNP 12 months
Other Change in Left Ventricular Ejection Fraction (LVEF) at 12 months Measurement of LVEF before and at 12 months after implant using echocardiography 12 months
Other Incidence of atrial tachyarrhythmia events Atrial arrhythmia event measured through cIED 5.5 years
Primary A combined clinical endpoint of all-cause mortality and hospitalization for heart failure The primary efficacy outcome will be described using Kaplan-Meier freedom from event curves over time, with event-free survival compared between assigned treatment arms using a logrank test, stratified by levels of the two factors (LVEF (=35% vs. 36 to 50%) and conduction abnormality (LBBB vs non-LBBB)) used for randomization. 5.5 years
Secondary Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) item score measured before and at 12 months after implant. 12 months
Secondary Change in composite endpoint comprised of death, first hospitalization for worsening HF and left ventricular end systolic volume index (LVESVi) at 5.5 years Secondary endpoint measured from all cause death, first hospitalization for heart failure and echocardiography on left ventricular end-systolic volume index (LVESVi) in the His/LBBP vs. BIV-BiVP arm 5.5 years
Secondary Death from any cause at 5.5 years Secondary endpoint measured from all cause death 5.5 years
Secondary Death from any cardiovascular cause at 5.5 years Secondary endpoint measured from death due to cardiovascular causes 5.5 years
Secondary Hospitalization for heart failure at 5.5 years Secondary endpoint measured from first hospitalization for heart failure 5.5 years
Secondary Cardiovascular hospitalization at 5.5 years Secondary endpoint measured from first hospitalization for cardiovascular disease 5.5 years
Secondary Change in NYHA Classification at 12 months Secondary endpoint measured from New York Heart Association class 12 months
Secondary Change in Six Minute Walk Test performance at 12 months Secondary endpoint measured from Six Minute Walk Test 12 months
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