Status:
COMPLETED
Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
Lead Sponsor:
Duke University
Collaborating Sponsors:
Medtronic
Abbott
Conditions:
Tricuspid Valve Insufficiency
Right Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03775759
Start Date
August 22 2018
End Date
February 15 2023
Last Update
June 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710