Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study (TVVAD)
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|ClinicalTrials.gov Identifier: NCT03775759|
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tricuspid Valve Insufficiency Right Heart Failure Heart Failure||Procedure: Tricuspid valve repair or replacement Other: Medical management of tricuspid regurgitation||Not Applicable|
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
- 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 month visit, and a six minute walk test at three and 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled, non-blinded, single center|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Experimental: Study arm
Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy
Procedure: Tricuspid valve repair or replacement
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.
Active Comparator: Control arm
LVAD implantation plus medical therapy
Other: Medical management of tricuspid regurgitation
The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.
- Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively [ Time Frame: 6 months post-operatively ]Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775759
|Contact: Yuting P Chiang, M.D.||firstname.lastname@example.org|
|Contact: Carmelo Milano, M.D.||email@example.com|