The TRICURE EFS Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2031-03-31

Brief Summary

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Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Detailed Description

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The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

Conditions

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Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcatheter Tricuspid Valve Replacement

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Group Type EXPERIMENTAL

Transcatheter Tricuspid Valve Replacement

Intervention Type DEVICE

Replacement of the tricuspid valve through a transcatheter approach

Interventions

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Transcatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach

Intervention Type DEVICE

Other Intervention Names

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TRiCares Topaz Tricuspid Valve Replacement System

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria

* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susheel Kodali, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center/ NewYork Presbyterian Hospital

Gorav Ailawadi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital and Health Systems

Locations

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Piedmont Healthcare Inc.

Atlanta, Georgia, United States

Site Status RECRUITING