AI-Guided Left Bundle Branch Area Pacing

NCT ID: NCT07206602

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AI-guided

Group Type EXPERIMENTAL

AI-assisted Left Bundle Branch Area Pacing

Intervention Type DEVICE

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

Control

Group Type ACTIVE_COMPARATOR

Left Bundle Branch Area Pacing

Intervention Type PROCEDURE

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

Interventions

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AI-assisted Left Bundle Branch Area Pacing

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

Intervention Type DEVICE

Left Bundle Branch Area Pacing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Fatima M. Ezzeddine

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatima Ezzeddine

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Joseph Abdel Messih

Role: CONTACT

507-422-3967

Other Identifiers

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25-007700

Identifier Type: -

Identifier Source: org_study_id

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