AI-guided left bundle branch area pacing for heart failure with reduced ejection fraction
Official title: A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure
Run by Mayo Clinic · NCT07206602 · Data updated 2026-11-12
This trial tests whether an AI-guided method for placing left bundle branch area pacing leads helps people with heart failure and reduced ejection fraction have better CRT response and clinical outcomes than conventional placement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 224 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 23, 2026 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT07206602 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with heart failure on guideline-directed medical therapy, LVEF <50% within 6 months, resting QRS ≥130 ms or anticipated/actual RV pacing >40%, and an AI-ECG probability of low LVEF >0.5 are ideal candidates.
✕Probably not a fit
Patients with preserved ejection fraction (≥50%), those who cannot comply with follow-up, pregnant individuals, or those who do not meet the QRS/pacing or AI-ECG criteria are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants who meet heart failure, ejection fraction, and pacing criteria will undergo left bundle branch area pacing placed either with an AI-guided system or with standard operator-guided technique. The study compares CRT response rates and clinical outcomes between the AI-assisted and conventional placement groups. Eligible adults must have LVEF <50%, a resting QRS ≥130 ms or anticipated/right ventricular pacing >40%, be on guideline-directed medical therapy, and have an AI-ECG probability of low LVEF >0.5. Follow-up visits and device-based assessments will track changes in cardiac function and clinical events at prespecified intervals.
Why it matters
Potential benefit: If successful, AI-guided placement could increase CRT response rates and improve heart function, symptoms, and potentially reduce hospitalizations.
How similar studies have gone: Left bundle branch area pacing has shown promise in prior studies as an alternative to traditional CRT, but using AI to guide lead placement is a newer approach with limited clinical data to date.
Who can join: the full rules
Show full inclusion / 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
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Fatima Ezzeddine — Mayo Clinic
- Study coordinator: Joseph Abdel Messih
- Email: mansour.joseph@mayo.edu
- Phone: 507-422-3967
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.