CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Harpoon Artificial ePTFE Chordsdevice
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/NCT02768870
NCT02768870N/ACompleted
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Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial

Edwards Lifesciences·interventional·Posted May 11, 2016·Updated Jan 11, 2024

In Brief

A clinical study evaluating Harpoon Artificial ePTFE Chords for Mitral Valve Regurgitation and 2 related conditions. Completed, enrolled 26 participants across 4 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
CountriesItaly, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 11, 2016
Enrollment StartApr 28, 2016
Primary CompletionNov 6, 2017
Study CompletionSep 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.1 years ago

Interventions

Harpoon Artificial ePTFE Chordsdevice

It is anticipated that use of the Harpoon device could achieve similar outcomes to open cardiac surgery while decreasing the invasiveness of mitral valve repair.