Clinical trial NCT03775759: Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
Official title: Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Right Heart Failure
Heart Failure
Keywords: Left ventricular assist device
Tricuspid regurgitation
Right heart failure
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Abbott
First posted: 2018-12-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, non-blinded, single center
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
timeFrame: 6 months post-operatively
measure: Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
timeFrame: 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: 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.