Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775759
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University

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.

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

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 month visit, and a six minute walk test at three and 6 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled, non-blinded, single center
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Yuting P Chiang, M.D. 919-970-5318 ypc2@duke.edu
Contact: Carmelo Milano, M.D. 919-684-3243 carmelo.milano@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Yuting Chiang, M.D.    919-970-5318    ypc2@duke.edu   
Contact: Muath Bishawi, M.D.    631-578-2092    muath.bishawi@duke.edu   
Sponsors and Collaborators
Duke University
Medtronic
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03775759    
Other Study ID Numbers: Pro00072372
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Duke University:
Left ventricular assist device
Tricuspid regurgitation
Right heart failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases