Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

Conditions

• Heart Failure - NYHA II - IV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CRT-D with a Quadripolar LV lead — DEVICE
  Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.
• CRT-D with INGEVITY+ pace/sense lead — DEVICE
  Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), INGEVITY+ pace/sense Lead (implanted in the LBBA)

Study Details

This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Key Dates

Start date

Oct 22, 2025

Status verified

Jun 2026

Primary completion

Nov 30, 2029

Completion

Nov 30, 2029

Study Design

Enrollment

850 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: CRT Cohort
  Participants will be randomized, implanted with a BSC CRT-D device using a Quadripolar lead, and device programmed to the respective cohort.
• Experimental: LBBA Cohort
  Participants will be randomized, implanted with a BSC CRT-D using the INGEVITY+ pace/sense lead implanted in the LBBA, and device programmed to the respective cohort.

Primary Outcome Measure

Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion. [ Time Frame: Through study completion, up to maximum of 5 years ]

Central Contacts

• Jacqueline Beaulieu
  1-800-227-3422
  [email protected]

Locations (32)

Find similar trials in Huntsville, AL

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