RECRUITING

Left vs Left Randomized Clinical Trial

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Conditions

Heart FailureHeart Failure With Reduced Ejection FractionAV BlockLBBBRBBBIntraventricular Conduction DelayPacing-Induced Cardiomyopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial

Quick Facts

Study Start:2023-09-13
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05650658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women 18 years of age or older.
  2. * A LVEF ≤ 50% within 6 months prior to enrollment.
  3. * 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%.
  4. * Are optimized on HF guideline directed medical therapy according to current HF published guidelines.
  1. * Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
  2. * 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.
  3. * Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
  4. * Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
  5. * Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
  6. * Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
  7. * Expected to receive left ventricular assist device or heart transplantation within 6 months.
  8. * Participants with severe valvular disease (e.g., aortic stenosis).
  9. * Have a life expectancy of less than 12 months.
  10. * Participants with irreversible brain damage from preexisting cerebral disease.
  11. * Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
  12. * Participants participating in any other interventional cardiovascular clinical trial.
  13. * Participants who would be unable to return for follow-up visits due to the distance from the clinic.
  14. * Participants who do not anticipate being a resident of the area for the scheduled duration of the trial.

Contacts and Locations

Study Contact

Mihail G Chelu, MD, PhD
CONTACT
7137987291
leftvsleft@bcm.edu
Merin Thomas
CONTACT
7137987291
merin.thomas@bcm.edu

Principal Investigator

Mihail G Chelu, MD, PhD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Kenneth A Ellenbogen, MD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Rush University
Chicago, Illinois, 60612
United States
University of Chicago
Chicago, Illinois, 60637
United States
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania, 18510
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Mihail G Chelu, MD, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine
  • Kenneth A Ellenbogen, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-13
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2023-09-13
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

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