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

Not Applicable

Completed

• Conditions: Tricuspid Valve Insufficiency; Right Heart Failure; Heart Failure
• Interventions: Procedure: Tricuspid valve repair or replacement; Other: Medical management of tricuspid regurgitation

• Registration Number: NCT03775759
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-08-22
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm	Tricuspid valve repair or replacement	Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy
Control arm	Medical management of tricuspid regurgitation	LVAD implantation plus medical therapy

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States