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| Name | Class |
|---|---|
| Sharpe-Strumia Research Foundation | OTHER |
| Medtronic | INDUSTRY |
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The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right ventricular septal pacing followed by left bundle branch area pacing | Device | All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in global longitudinal strain (GLS%) | Primary efficacy outcome | 9 months |
| Change in left ventricular ejection fraction (LVEF%) | Primary efficacy outcome | 9 months |
| Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation | Primary safety endpoint | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to device function | 18 months | |
| Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ) | 9 months | |
| Functional capacity measured using the New York Heart Association functional classification (NYHA) |
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Inclusion Criteria:
Subject has at least one of these conduction disturbances:
Subject has undergone TAVR (any valve system) in the last four weeks
Subject is receiving a first-time pacemaker implant
Subject's most recent documented ejection fraction (by any method) within the past 90 days prior to study enrollment is > 50% (≥45% if visually estimated at the time of enrollment)
Subject is a male or female at least 18 years old at the time of consent
Subject is able to receive a left sided pectoral implant
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Keramati, MD | Lankenau Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States | ||
| Valley Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39525828 | Derived | Liskov S, Olleik F, Jarrett H, Abramson S, Kowey P, Schaller RD, Vijayaraman P, Habibi M, Bansal S, Heimann M, Cox S, Keramati AR. Comparing Left Bundle Branch Area vs Right-Ventricular Septal Pacing in High-Degree Conduction Disease After Transcatheter Aortic Valve Replacement: Randomized Trial Study Protocol. CJC Open. 2024 May 18;6(9):1058-1065. doi: 10.1016/j.cjco.2024.05.006. eCollection 2024 Sep. |
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|
| Left bundle branch area pacing followed by right ventricular septal pacing | Device | All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study. |
|
| 9 months |
| Six minute walk test score | 9 months |
| Hospitalizations for heart failure | 18 months |
| Mortality | 18 months |
| Right ventricular global longitudinal strain (RVGLS%) | 9 months |
| Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI) | 9 months |
| Interventricular mechanical delay (IVMD) | 9 months |
| Left ventricular end-systolic volume | 9 months |
| Left ventricular stroke volume | 9 months |
| Severity of tricuspid regurgitation | 18 months |
| Severity of mitral regurgitation | 18 months |
| Left bundle branch area pacing lead pacing threshold | 18 months |
| Left bundle branch area pacing lead sensed R wave amplitude | 18 months |
| Left bundle branch area pacing lead impedence | 18 months |
| Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration | 9 months |
| Ridgewood |
| New Jersey |
| 07450 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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