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

June 12, 2023 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post-operatively
Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Medtronic
Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2018

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00072372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Tricuspid valve repair or replacement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe