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TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR

NCT03227757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-11-06

Study results available
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Summary

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.

Conditions

  • Tricuspid Valve Insufficiency

Interventions

DEVICE

Tricuspid Valve Repair System

Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Prof. Georg Nickenig · University Hospital, Bonn

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-11-14
Completion
2024-05-30
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227757 on ClinicalTrials.gov