Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Planned LVAD implantation (either destination or bridge indication) 18 years of age or older Patients wilith mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study. TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) quantified as moderate or severe with normal tricuspid valve leaflets Exclusion Criteria Previous tricuspid valve surgery Previous LVAD Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization Preimplant RVAD or ECMO Planned thoracotomy approach for LVAD implantation Pregnant women 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: Study arm (Arm A) - Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy Control arm (Arm B) - LVAD implantation plus medical therapy (the medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population) 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.

Official Title
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Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study

Conditions
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Tricuspid Valve Insufficiency, Right Heart Failure, Heart Failure

Intervention / Treatment
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* Procedure: Tricuspid valve repair or replacement
* Other: Medical management of tricuspid regurgitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned LVAD implantation (either destination or bridge indication) 18 years of age or older Patients will mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study. Patients with moderate or graeter TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) will qualify for randomization Exclusion Criteria: Previous tricuspid valve surgery Previous left ventricular assist device Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization Preimplant RVAD or ECMO Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled, non-blinded, single center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy | Procedure: Tricuspid valve repair or replacement<br>* Available rings used at Duke include the Tri-Ad™ Adams Tricuspid Ring by Medtronic, the TAILOR™ 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 Mosaic™ 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 Medical™ Mechanical Heart Valve by St. Jude Medical/Abbott.<br>|
| Active Comparator: Control arm<br>LVAD implantation plus medical therapy | Other: Medical management of tricuspid regurgitation<br>* The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular assist device, Tricuspid regurgitation, Right heart failure