CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 572 enrolled
Drug / intervention
TriClipTM Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03904147
NCT03904147N/AActive
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Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

Abbott Medical Devices·interventional·Posted Apr 5, 2019·Updated Dec 19, 2024

In Brief

A clinical study evaluating TriClipTM Device for Tricuspid Regurgitation. Active but no longer recruiting, targeting 572 participants across 76 sites in 5 countries.

Detailed Summary

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTricuspid Regurgitation
CountriesCanada, Germany, Italy, Spain, United States
Collaborators--

Timeline

N/AActive
20192020202120222023202420252026202720282029
First PostedApr 5, 2019
Enrollment StartAug 21, 2019
Primary CompletionNov 18, 2022
Study CompletionApr 1, 2029
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.2 years ago

Interventions

TriClipTM Devicedevice

Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation