CE Mark Study for the Harpoon Medical Device (TRACER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02768870|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Regurgitation Mitral Valve Prolapse Mitral Valve Insufficiency||Device: Harpoon Artificial ePTFE Chords||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||October 2020|
Experimental: Harpoon Medical Device
This is a prospective, single arm, nonrandomised, multi-center EU study to demonstrate the performance and safety of the Harpoon Medical device in patients with degenerative MR.
Device: Harpoon Artificial ePTFE Chords
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.
- Procedural success during the first 30 days [ Time Frame: 30 days ]To demonstrate that the Harpoon Medical device performs as designed and has the ability to successfully implant one or more ePTFE chordae tendineae on the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.
- Freedom from SAE's during the first 30 days [ Time Frame: 30 days ]Procedure freedom from Serious Adverse Events (SAEs) during the ePTFE implantation procedure, at discharge, and at 30 days follow-up shall be tracked and recorded. Rates are expected to be not significantly worse than conventional mitral valve surgery.
- Long Term Procedural Success [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months ]Severity of mitral regurgitation at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months follow-up shall be tracked and recorded.
- Freedom from SAE's post implant > 30 days [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months ]Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months follow-up shall be tracked and recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768870
|Ospedale San Raffaele Hospital|
|Milan, Italy, 20132|
|University Hospital Padova|
|Padova, Italy, 351278|
|The Royal Brompton and Harefield NHS Foundation Trust|
|London, United Kingdom, SH3 6NP|
|University Hospital Southampton NHS Trust|
|Southampton, United Kingdom, SO16 6YD|
|Principal Investigator:||Gino Gerosa, MD||University Hospital Padova|
|Principal Investigator:||Ottavio Alfieri, MD||OSR San Raffaele Hospital|
|Principal Investigator:||Alison Duncan, MD||The Royal Brompton Hospital|