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

NCT03775759 | Completed DMC

• 1 other identifier: Pro00072372
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Valve Insufficiency; Right Heart Failure; Heart Failure

Keywords

Left ventricular assist device; Tricuspid regurgitation; Right heart failure

Outcome Measures

Primary Outcomes (2)

• Proportion of patients experiencing moderate or greater right heart failure within 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

  Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria

  12 months post-operatively

Study Arms (2)

Study arm

EXPERIMENTAL

Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy

Procedure: Tricuspid valve repair or replacement

Control arm

ACTIVE COMPARATOR

LVAD implantation plus medical therapy

Other: Medical management of tricuspid regurgitation

Interventions

Tricuspid valve repair or replacement PROCEDURE

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.

Study arm

Medical management of tricuspid regurgitation OTHER

The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned LVAD implantation (either destination or bridge indication)
• years of age or older
• Patients with moderate or graeter TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) will qualify for randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Medtronic: collaborator
• Abbott: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 36639288 RESULT

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure

Interventions

Replantation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled, non-blinded, single center

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: August 22, 2018
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)