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Recruiting NCT07206602

AI-Guided Left Bundle Branch Area Pacing

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-assisted Left Bundle Branch Area Pacing, Left Bundle Branch Area Pacing.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure

Overview

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.

Interventions

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

Primary outcome measures

  • CRT response rate [Time frame: Baseline, 6 months]
Secondary outcome measures (12)
  • NYHA (New York Heart Association) Class [Time frame: Baseline, 6 months]
  • Number of Hospitalizations [Time frame: 6 months]
  • Number of Deaths [Time frame: 6 months]
  • Left Ventricular Linear Dimensions [Time frame: Baseline, 3 months]
  • Left Ventricular Linear Volume [Time frame: Baseline, 3 months]
  • Procedural success: LBBAP-conventional arm [Time frame: Baseline]
  • Procedural success: AI-LBBAP arm [Time frame: Baseline]
  • Fluoroscopy time [Time frame: Baseline, Approximately 30 minutes]
  • Total procedure time [Time frame: Baseline, Approximately 1-2 hours]
  • Lead pacing thresholds [Time frame: Baseline]
  • Impedance [Time frame: Baseline]
  • Sensing Parameters [Time frame: Baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07206602 · 25-007700

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗