Study Results
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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NOT_YET_RECRUITING
NA
224 participants
INTERVENTIONAL
2026-01-31
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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AI-guided
AI-assisted Left Bundle Branch Area Pacing
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology
Control
Left Bundle Branch Area Pacing
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
Left Bundle Branch Area Pacing
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to follow-up
* Pregnancy
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Fatima M. Ezzeddine
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
Countries
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Central Contacts
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Other Identifiers
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25-007700
Identifier Type: -
Identifier Source: org_study_id
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