Heart FailureHeart and circulationDeviceProcedure
What this study is
The purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes.
What's being tested
- AI-assisted Left Bundle Branch Area Pacing
Intervention · DEVICE
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology
- Left Bundle Branch Area Pacing
Intervention · PROCEDURE
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure
Study details
- Official title
- A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure
- Sponsor
- Mayo Clinic
- Conditions
- Heart Failure
- Enrolling
- 224 people
- Starts
- 2026-01-23
- Est. completion
- 2027-11
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age: 18 years or older.
- Left Ventricular Ejection Fraction (LVEF): <50% within 6 months prior to enrollment.
- QRS Duration: Resting QRS duration ≥ 130 ms on ECG OR anticipated right ventricular pacing > 40% OR device in place with right ventricular pacing > 40% within 6 months prior to enrollment.
- Medical Therapy: Optimized on guideline-directed medical therapy for heart failure.
- AI-ECG probability of low LVEF: >0.5
You can't join if
- Age less than 18 years old
- Inability to follow-up
- Pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Fatima M Ezzeddine, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 25-007700
Principal investigator
Fatima Ezzeddine
Mayo Clinic
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.