AI-Guided Left Bundle Branch Area Pacing

Mayo Clinic

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Procedure: Left Bundle Branch Area Pacing; Device: AI-assisted Left Bundle Branch Area Pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT07206602

25-007700

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Age less than 18 years old
• Inability to follow-up
• Pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups

AI-guided

Experimental group

Treatment:

Device: AI-assisted Left Bundle Branch Area Pacing

Control

Active Comparator group

Treatment:

Procedure: Left Bundle Branch Area Pacing