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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL159401 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-Op Prophylactic VT ablation | Experimental | Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support |
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| Conventional Management | Active Comparator | To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-Op Prophylactic VT ablation | Procedure | For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent VTA | Total VTA events, after accounting for the competing risk of death | Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure. | Number of participants with any of the following: hospitalization, stroke or right heart failure. Right heart failure assessed by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria. | Post LVAD implant until end of follow-up, approximately 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Colasurdo | Contact | 585-275-1054 | ann_colasurdo@urmc.rochester.edu | |
| Kathy Honsinger | Contact | 585-273-1899 |
| Name | Affiliation | Role |
|---|---|---|
| David Huang, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Recruiting | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38103723 | Derived | Oates CP, Lam PH, Lawrence L, Bigham G, Meda NS, Basyal B, Hadadi CA, Rao SD, Hockstein M, Shah M, Sheikh FH. Early Ventricular Arrhythmias After Left Ventricular Assist Device Implantation. J Card Fail. 2024 Aug;30(8):1018-1027. doi: 10.1016/j.cardfail.2023.11.018. Epub 2023 Dec 15. |
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| Conventional Management | Other | To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued |
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| Mean duration of LVAD implant (and ablation) surgery | Admission for LVAD implant until hospital discharge (approximately 2-4 weeks) |
| Mean duration of ablation | Admission for LVAD implant until hospital discharge (approximately 2-4 weeks) |
| Mean rate of peri-procedural complication | Peri-procedural complications include bleeding, infection, and need for repeat operation. | Admission for LVAD implant until hospital discharge (approximately 2-4 weeks) |
| Mean Length of stay in the intensive care unit after LVAD implant | Admission for LVAD implant until hospital discharge (approximately 2-4 weeks) |
| UCLA Cardiac Arrthmia Center | Recruiting | Los Angeles | California | 90095 | United States |
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| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Medstar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Piedmont Heart Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Ascension St. Vincent Indianapolis | Recruiting | Indianapolis | Indiana | 46260 | United States |
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| Univedrsity of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| Columbia University Medical Center | Recruiting | New York | New York | 10026 | United States |
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| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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