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NCT05650658 · ClinicalTrials.gov registry record · NA
Left vs Left Randomized Clinical Trial
A NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 2,136
- Enrollment target
- 20
- Study locations
NCT05650658: Recruiting NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by Baylor College of Medicine.
NCT05650658 is a NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 2,136 participants, roughly in line with the 2,044-participant average among 397 other Heart Failure trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05650658, a NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,136 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE His/LBBP
- DEVICE BiVP
Study Locations (20)
Florida
- Heart Rhythm Solutions - Davie
- University of Florida Jacksonville - Jacksonville
- Mount Sinai Medical Center of Florida, Inc. - Miami Beach
- Cleveland Clinic Florida - Palm Beach Gardens
- Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC - South Pasadena
- University of South Florida - Tampa
Illinois
- Rush University - Chicago
- University of Chicago - Chicago
- Northwestern University - Evanston
- CIS Clinical Research Corporation - Naperville
Arizona
- Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ - Gilbert
- University of Arizona College of Medicine- Phoenix - Tucson
Colorado
- University of Colorado (Anschutz Medical Campus) - Denver
- South Denver Cardiology Associates - Littleton
Connecticut
- Hartford Hospital - Hartford
- Yale University - New Haven
Arkansas
- University of Arkansas for Medical Sciences (UAMS) - Little Rock
California
- University of California San Diego - La Jolla
Indiana
- Trustees of Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,136 participants |
| Start Date | 2023-09-13 |
| Est. Completion | 2029-06-30 |
| Phase | NA |
What NCT05650658 shows while recruiting
NCT05650658 is an interventional study that assigns participants to a tested intervention. Its 2,136 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 2,044-participant average among 397 other Heart Failure trials with a reported enrollment target.
The record links to 7 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which His/LBBP is the first listed.
NCT05650658 names 20 study sites across 9 states, led by Florida, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT05650658 about?
NCT05650658 is a clinical study titled "Left vs Left Randomized Clinical Trial". 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...
What is the current status of trial NCT05650658?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,136 participants. The study started on 2023-09-13. Estimated completion is 2029-06-30.
What conditions does trial NCT05650658 study?
This clinical trial studies the following conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB, RBBB.
What interventions are being tested in trial NCT05650658?
The interventions under investigation include: His/LBBP (DEVICE), BiVP (DEVICE).
Who is sponsoring clinical trial NCT05650658?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05650658 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05650658's enrollment target sits among peer trials
2,136 43rd of 397 higher than 355 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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