Safety and Effectiveness of Left Bundle Branch Area Pacing for Heart Failure
This study is comparing two ways to pace the heart for people with heart failure (NYHA II - IV). One method is the standard Cardiac Resynchronization Therapy (CRT-D with a Quadripolar LV lead), which places a pacing wire on the surface of the heart's lower left chamber. The other method, Left Bundle Branch Area Pacing (CRT-D with INGEVITY+ pace/sense lead), places a pacing wire in a different area of the heart called the Left Bundle Branch Area. You might be able to join if you are 18 or older, need a CRT-D device, and have a specific heart condition with a low pumping ability (LVEF ≤ 35%). The study will look at how well these methods reduce serious heart-related events and complications over up to five years. The study plans to enroll 850 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing two different pacing methods for heart failure. Participants will be assigned to one of the two treatment groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed through study completion, for a maximum of 5 years, to monitor for heart-related events and complications.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
At a glance
Conditions
NCT07069738
Where you'd take part
This study runs at 40 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
AdventHealth Tampa
Tampa, Floridano site contact published
Recruiting
Alta Bates Summit Medical Center
Oakland, Californiano site contact published
Recruiting
Arrhythmia Research Group
Jonesboro, Arkansasno site contact published
Recruiting
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakotano site contact published
Recruiting
Baptist Hospital East Louisville
Louisville, Kentuckyno site contact published
Recruiting
Capital Cardiology Associates
Albany, New Yorkno site contact published
Recruiting
Cardiology Associates Medical Group, Inc.
Ventura, Californiano site contact published
Recruiting
Cedars Sinai Medical Center
Los Angeles, Californiano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.Through study completion, up to maximum of 5 years
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.
- System-related complication-free rate12 months
The primary safety endpoint is System-related complication-free rate of LBBAP at 12 months. This will be a single-arm analysis of the LBBAP group compared to a performance goal