AI-Guided Left Bundle Branch Area Pacing
A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure
1 other identifier
interventional
224
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedStudy Start
First participant enrolled
January 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
February 18, 2026
February 1, 2026
1.8 years
September 26, 2025
February 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
CRT response rate
CRT response is defined as an absolute increase of \>5% in left ventricular ejection fraction (LVEF) after 6 months of CRT
Baseline, 6 months
Secondary Outcomes (12)
NYHA (New York Heart Association) Class
Baseline, 6 months
Number of Hospitalizations
6 months
Number of Deaths
6 months
Left Ventricular Linear Dimensions
Baseline, 3 months
Left Ventricular Linear Volume
Baseline, 3 months
- +7 more secondary outcomes
Study Arms (2)
AI-guided
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology
Eligibility Criteria
You 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 may not qualify if:
- Age less than 18 years old
- Inability to follow-up
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatima Ezzeddine
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 26, 2025
First Posted
October 3, 2025
Study Start
January 23, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share