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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-guided | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted Left Bundle Branch Area Pacing | Device | Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| CRT response rate | CRT response is defined as an absolute increase of >5% in left ventricular ejection fraction (LVEF) after 6 months of CRT | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Abdel Messih | Contact | 507-422-3967 | mansour.joseph@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fatima Ezzeddine | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Left Bundle Branch Area Pacing | Procedure | Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure |
|
| Number of Hospitalizations | Number of Hospitalizations will be determined by the number of participants that are hospitalized for heart failure. | 6 months |
| Number of Deaths | Number of patient deaths by any cause | 6 months |
| Left Ventricular Linear Dimensions | Left Ventricular Linear Dimensions will be measured by an echocardiogram. A lower value indicates better cardiac function. | Baseline, 3 months |
| Left Ventricular Linear Volume | Left Ventricular Linear Volume will be measured by an echocardiogram. A lower value indicates better cardiac function. | 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:
| 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. | 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) | 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) | Baseline, Approximately 1-2 hours |
| Lead pacing thresholds | Lead pacing thresholds will be measured in Voltage at millisecond. | Baseline |
| Impedance | Impedance will be measured in Ohms. | Baseline |
| Sensing Parameters | Sensing Parameters will be measured in mV (milliVolts) | Baseline |