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NCT Number: NCT07206602

AI-Guided Left Bundle Branch Area Pacing

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Fatima M Ezzeddine, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-assisted Left Bundle Branch Area Pacing

Device

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

Left Bundle Branch Area Pacing

Procedure

Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure

Primary outcomes

  1. CRT response rate

    Time frame: 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 outcomes

  1. NYHA (New York Heart Association) Class

    Time frame: 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.

  2. Number of Hospitalizations

    Time frame: 6 months

    Number of Hospitalizations will be determined by the number of participants that are hospitalized for heart failure.

  3. Number of Deaths

    Time frame: 6 months

    Number of patient deaths by any cause

  4. Left Ventricular Linear Dimensions

    Time frame: Baseline, 3 months

    Left Ventricular Linear Dimensions will be measured by an echocardiogram. A lower value indicates better cardiac function.

  5. Left Ventricular Linear Volume

    Time frame: Baseline, 3 months

    Left Ventricular Linear Volume will be measured by an echocardiogram. A lower value indicates better cardiac function.

  6. Procedural success: LBBAP-conventional arm

    Time frame: 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

  7. Procedural success: AI-LBBAP arm

    Time frame: 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.

  8. Fluoroscopy time

    Time frame: 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)

  9. Total procedure time

    Time frame: 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)

  10. Lead pacing thresholds

    Time frame: Baseline

    Lead pacing thresholds will be measured in Voltage at millisecond.

  11. Impedance

    Time frame: Baseline

    Impedance will be measured in Ohms.

  12. Sensing Parameters

    Time frame: Baseline

    Sensing Parameters will be measured in mV (milliVolts)

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Abdel Messih

CONTACT

[email protected]

507-422-3967

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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