RecruitingNot applicable

His-Bundle Corrective Pacing in Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (14)

AZ

  • University of Arizona · Phoenix, AZ 85006Mathew Freeman · Study contactRoderick Tung · Principal investigatorMore trials in Phoenix

CA

  • Cedars-Sinai Medical Center · Los Angeles, CA 90048Kelsey Duggin · Study contactEric Braunstein · Principal investigatorMore trials in Los Angeles

FL

  • University of South Florida · Tampa, FL 33606Jacky He · Study contactBengt Herweg · Principal investigatorMore trials in Tampa

IL

  • Northwestern Memorial Hospital · Chicago, IL 60611Madison Stat · Study contactNishant Verma · Principal investigatorMore trials in Chicago
  • Rush University Medical Center · Chicago, IL 60612Samreen Ahmed · Study contactTimothy Larsen · Principal investigatorMore trials in Chicago
  • University of Chicago · Chicago, IL 60637Shahram Sarrafi · Study contactGaurav Upadhyay · Principal investigatorMore trials in Chicago

NC

  • Mission Health · Asheville, NC 28803Jordan Dalton · Study contactMichael Manogue · Principal investigatorMore trials in Asheville

NJ

  • Valley Health System · Ridgewood, NJ 07450Sequoia Young · Study contactSuneet Mittal · Principal investigatorMore trials in Ridgewood

NY

  • Weill Cornell Medical College · New York, NY 10021Penn Collins · Study contactJim Cheung · Principal investigatorMore trials in New York
  • Mount Sinai Hospital · New York, NY 10029Shahryar Kamran · Study contactJacob Koruth · Principal investigatorMore trials in New York

PA

  • University of Pennsylvania · Philadelphia, PA 19104Mary Gnap · Study contactRobert Schaller · Principal investigatorMore trials in Philadelphia
  • Geisinger Wyoming Valley · Wilkes-Barre, PA 18711Grace Hughes · Study contactPugazhendhi Vijayaraman · Principal investigatorMore trials in Wilkes-Barre

VA

  • Virginia Commonwealth University · Richmond, VA 23298Anya Baranova · Study contactKenneth Ellenbogen · Principal investigatorMore trials in Richmond

VT