His-Bundle Corrective Pacing in Heart Failure

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Rochester
Study ID
NCT05265520
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Resynchronization Therapy
  • Heart Failure
  • His-bundle Pacing
  • Right Bundle-Branch Block

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • His-CRT implantation — PROCEDURE
    The pathophysiological process is utilized in His-Bundle corrective pacing, 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 endocardial lead.
  • BIV-CRT implantation — PROCEDURE
    Biventricular cardiac resynchronization therapy 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.

Study Details

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).

Key Dates

Start date
Dec 2, 2022
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: His-CRT implantation
    His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.
  • Active Comparator: BIV-CRT implantation
    BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Primary Outcome Measure

Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB) [ Time Frame: 6 month ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of ArizonaPhoenixArizona85006
Mathew Freeman
Roderick Tung (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Kelsey Duggin
Eric Braunstein (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Jacky He
Bengt Herweg (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Madison Stat
Nishant Verma (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Samreen Ahmed
Timothy Larsen (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Shahram Sarrafi
Gaurav Upadhyay (PRINCIPAL_INVESTIGATOR)
Valley Health SystemRidgewoodNew Jersey07450
Sequoia Young
Suneet Mittal (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Shahryar Kamran
Jacob Koruth (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10021
Penn Collins
Jim Cheung (PRINCIPAL_INVESTIGATOR)
Mission HealthAshevilleNorth Carolina28803
Jordan Dalton
Michael Manogue (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Mary Gnap
Robert Schaller (PRINCIPAL_INVESTIGATOR)
Geisinger Wyoming ValleyWilkes-BarrePennsylvania18711
Grace Hughes
Pugazhendhi Vijayaraman (PRINCIPAL_INVESTIGATOR)
University of VermontBurlingtonVermont05401
Amy Henderson
Virginia Commonwealth UniversityRichmondVirginia23298
Anya Baranova
Kenneth Ellenbogen (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Arizona· Phoenix, AZCedars-Sinai Medical Center· Los Angeles, CAUniversity of South Florida· Tampa, FLNorthwestern Memorial Hospital· Chicago, ILRush University Medical Center· Chicago, ILUniversity of Chicago· Chicago, IL

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