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

• Sponsor: Duke University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03775759
• Collaborator: Medtronic (Industry), Abbott (Industry)
• Enrollment: 71
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 57.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled, non-blinded, single centerRandomized 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: Aug 22, 2018
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively [6 months post-operatively]

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

2. Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively [12 months post-operatively]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Medtronic
• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03775759
• Other Study ID Numbers: Pro00072372
• First Posted: Dec 14, 2018
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Heart Failure; Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Jul 1, 2022