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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 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.

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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.

Conditions Studied

Heart Failure Heart Failure With Reduced Ejection Fraction AV Block LBBB RBBB Intraventricular Conduction Delay Pacing-Induced Cardiomyopathy

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

FieldValue
Enrollment Target 2,136 participants
Start Date 2023-09-13
Est. Completion 2029-06-30
Phase NA

Sponsor

Baylor College of Medicine

616 total trials

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What the Registry Record Tells You About NCT05650658

The ClinicalTrials.gov registry entry for NCT05650658 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,136 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 2,044-participant average among 397 other Heart Failure trials with a reported enrollment target. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.