AI-Guided Left Bundle Branch Area Pacing

Not Applicable

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07206602
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-11-01
• Primary Completion: 2027-11
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CRT response rate	Baseline, 6 months	CRT response is defined as an absolute increase of \>5% in left ventricular ejection fraction (LVEF) after 6 months of CRT

Secondary Outcome Measures

Name	Time	Method
NYHA (New York Heart Association) Class	Baseline, 6 months	The New York Heart Association (NYHA) classification will be assessed using the NYHA questionnaire, which evaluates the extent of physical limitations caused by heart failure. This system categorizes patients into one of four classes, with higher classes indicating more severe functional impairment.
Number of Hospitalizations	6 months	Number of Hospitalizations will be determined by the number of participants that are hospitalized for heart failure.
Number of Deaths	6 months	Number of patient deaths by any cause
Left Ventricular Linear Dimensions	Baseline, 3 months	Left Ventricular Linear Dimensions will be measured by an echocardiogram. A lower value indicates better cardiac function.
Left Ventricular Linear Volume	Baseline, 3 months	Left Ventricular Linear Volume will be measured by an echocardiogram. A lower value indicates better cardiac function.
Procedural success: LBBAP-conventional arm	Baseline	LBBAP is considered successful if unipolar paced QRS morphology demonstrated a Qr or qR morphology in lead V1 along with any 1 of the following criteria: * Left bundle branch potential; * Transition to selective left bundle branch capture or left ventricular septal capture during threshold testing or programmed stimulation; * R-wave peak time \<90 ms in V5-V6; * V6-V1 interpeak interval \>44 ms
Procedural success: AI-LBBAP arm	Baseline	Procedural success is defined as improvement in the AI-ECG predicted likelihood of having a low LVEF from greater than 0.5 at baseline to less than 0.5 after LBBAP.
Fluoroscopy time	Baseline, Approximately 30 minutes	Fluoroscopy time will be determined by the amount of time that fluoroscopy is used to guide the left bundle branch area pacing (an average of 30 minutes)
Total procedure time	Baseline, Approximately 1-2 hours	Total procedure time will be determined by the start of the LBBAP procedure until completion (an average of 2 hours)
Lead pacing thresholds	Baseline	Lead pacing thresholds will be measured in Voltage at millisecond.
Impedance	Baseline	Impedance will be measured in Ohms.
Sensing Parameters	Baseline	Sensing Parameters will be measured in mV (milliVolts)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States