Recruiting

AI-Guided & Conventional LBBAP

Sponsor:

Mayo Clinic

Code:

NCT07206602

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AI-assisted Left Bundle Branch Area Pacing

Left Bundle Branch Area Pacing

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT07206602

Start date

Jan 23, 2026

Status verified date

Feb, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: AI-guided

active comparator: Control

Interventions

AI-assisted Left Bundle Branch Area Pacing

Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology

Left Bundle Branch Area Pacing

Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure

Primary outcome measure

  • CRT response rate [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Joseph Abdel Messih

507-422-3967mansour.joseph@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Fatima M Ezzeddine, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-18.