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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
224
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure
Mayo Clinic in Rochester
Rochester, Minnesota, United States
CRT response rate
CRT response is defined as an absolute increase of \>5% in left ventricular ejection fraction (LVEF) after 6 months of CRT
Time frame: Baseline, 6 months
NYHA (New York Heart Association) Class
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.
Time frame: Baseline, 6 months
Number of Hospitalizations
Number of Hospitalizations will be determined by the number of participants that are hospitalized for heart failure.
Time frame: 6 months
Number of Deaths
Number of patient deaths by any cause
Time frame: 6 months
Left Ventricular Linear Dimensions
Left Ventricular Linear Dimensions will be measured by an echocardiogram. A lower value indicates better cardiac function.
Time frame: Baseline, 3 months
Left Ventricular Linear Volume
Left Ventricular Linear Volume will be measured by an echocardiogram. A lower value indicates better cardiac function.
Time frame: Baseline, 3 months
Procedural success: LBBAP-conventional arm
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline
Procedural success: AI-LBBAP arm
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.
Time frame: Baseline
Fluoroscopy time
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)
Time frame: Baseline, Approximately 30 minutes
Total procedure time
Total procedure time will be determined by the start of the LBBAP procedure until completion (an average of 2 hours)
Time frame: Baseline, Approximately 1-2 hours
Lead pacing thresholds
Lead pacing thresholds will be measured in Voltage at millisecond.
Time frame: Baseline
Impedance
Impedance will be measured in Ohms.
Time frame: Baseline
Sensing Parameters
Sensing Parameters will be measured in mV (milliVolts)
Time frame: Baseline