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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Abbott | INDUSTRY |
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The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.
This study is a prospective, single center, randomized trial. Up to 280 subjects will be enrolled.
Inclusion Criteria - Potential subjects must meet all inclusion criteria to participate.
Exclusion Criteria
All subjects will undergo an intraoperative transesophageal echocardiogram (TEE) to evaluate their tricuspid valve. Subjects will be randomized in the operating room. Randomization will be stratified based on preoperative right ventricle dysfunction. Subjects will be randomized 1:1 to either of the following treatment arms:
Subjects will be monitored in the surgical and on the step down floor ICU, and follow-up data will be collected on subjects monthly from routine tests and clinic visits. This will include information on adverse events and any hospital readmissions, a quality of life questionnaire at their 6 and 12 month visit, and a six minute walk test at 3, 6, and 12 months. Cardiopulmonary exercise testing will be completed at 12 or greater months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy |
|
| Control arm | Active Comparator | LVAD implantation plus medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid valve repair or replacement | Procedure | Available rings used at Duke include the Tri-Adâ„¢ Adams Tricuspid Ring by Medtronic, the TAILORâ„¢ FLEXIBLE ANNULOPLASTY RING by St. Jude Medical/Abbott, and the Carpentier-Edwards Physio II Ring by Edwards LifeSciences. Available valves used at Duke include the Mosaicâ„¢ Mitral Orbutrator by Medtronic, the Carpentier-Edwardes PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis by Edwards LifeSciences, the On-X Mitral Valve, by CryoLife, the Carbomedics Prosthetic Heart Valve by LivaNova, and the St. Jude Medicalâ„¢ Mechanical Heart Valve by St. Jude Medical/Abbott. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively | Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria | 6 months post-operatively |
| Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively | Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria | 12 months post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36639288 | Result | Mendiola Pla M, Chiang Y, Nicoara A, Poehlein E, Green CL, Gross R, Bryner BS, Schroder JN, Daneshmand MA, Russell SD, DeVore AD, Patel CB, Katz JN, Milano CA, Bishawi M. Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial. J Thorac Cardiovasc Surg. 2024 May;167(5):1810-1820.e2. doi: 10.1016/j.jtcvs.2022.10.054. Epub 2022 Nov 16. | |
| 39313112 |
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Randomized controlled, non-blinded, single center
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| Medical management of tricuspid regurgitation | Other | The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population. |
|
| Derived |
| Mendiola Pla M, Russell SD, Milano CA, Chiang Y, Kang L, Poehlein E, Green CL, Benedetti F, Billard H, Bryner BS, Schroder JN, Daneshmand MA, Nicoara A, DeVore AD, Patel CB, Bishawi M. Late follow-up for a randomized trial of surgical treatment of tricuspid valve regurgitation in patients undergoing left ventricular assist device implantation. J Thorac Cardiovasc Surg. 2025 Jul;170(1):244-253.e3. doi: 10.1016/j.jtcvs.2024.09.023. Epub 2024 Sep 21. |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012092 | Replantation |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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