Mitral TRACER Trial
Research type
Research Study
Full title
Mitral Trans-Apical Chordal Echo-guided Repair (TRACER)Trial
IRAS ID
178652
Contact name
Alison Duncan
Contact email
Sponsor organisation
Harpoon Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
The main aim of the study is to find out if a new surgical procedure and medical device are suitable for the repair of your leaking mitral valve in your heart. Your leaking valve is commonly called Mitral Regurgitation. Mitral Regurgitation is caused when one of the four valves in your heart is not working properly. Each of your heart valves has two leaflets or flaps that work like two doors or a gateway from one part of the heart to the other.
When the leaflets are working well, by opening and closing together, blood flows normally through the heart. When one of these leaflets does not work well (close properly), blood flows the wrong way in your heart. This condition is called mitral valve prolapse and causes your mitral regurgitation.
To fix your Mitral Regurgitation, we will need to perform a surgical procedure to repair the prolapsed part of the leaflet. You will be taken to the operating theatre and put to sleep with general anesthesia. A very small incision, approximately 5 cm long, will be made on the left side of the chest.
Your surgical site will give the study doctor access to your heart to fix your mitral leaflet that is causing your mitral regurgitation. The study doctor will fix the leaflet by attaching a few new string to it which are fastened outside the heart - It is much like a fixing a parachute that has broken strings.
You will be monitored by echocardiography during the procedure. The echocardiography will take a video of your heart. Your study doctor will use these video pictures to make sure your valve is fixed and will not leak at the end of the procedure. The entire procedure lasts about two hours.
After the operation, you will wake up with a small scar on the left side of your chest. In about a week’s time you should be able to resume activities of normal living.Summary of Results
Mitral regurgitation occurs when the mitral valve of the heart stops working properly, causing blood to leak back into one of the chambers of the heart and interfering with the normal flow of blood through the heart. The current standard treatment of mitral regurgitation is surgical repair (or less frequently surgical replacement) of the leaky mitral valve which requires the chest to be opened, the heart stopped, and the patient's blood is circulated through a heart-lung machine. The Harpoon Medical device being tested in the TRACER study is a procedure that can repair the mitral valve through a less invasive surgical procedure than conventional cardiac surgery using an incision between the ribs on the left-side of the patient's chest (just underneath the nipple). Also in contrast to surgery, it is performed without stopping the patient's heart, so a heart and lung machine is not needed. The aim of the TRACER study was therefore to establish if the Harpoon medical device could reliably and durably repair a patient's leaking mitral valve without the need for conventional surgical intervention.
In the original application, the number of proposed patients for study was 20 per hospital site. The actual number recruited was 9 patients in London and 8 patients in Southampton. The original application suggested a 2 year follow-up. In August 2019, a substantial amendment permitted the study to be extended to allow patient follow-up up for 5 years. Over the course of the study, no patient died. In terms of study withdrawals, (i) one patient withdrew their consent, (ii) one patient was anatomically suitable for the Harpoon Medical device but declined by Sponsor due to severe respiratory disease, (iii) one patient was withdrawn from the study their requiring conversion to conventional open-heart surgery during the Harpoon Medical device procedure due to uncontrolled bleeding and this patient was subsequently followed for a 30 days safety period, (iv) one patient was withdrawn from the study due to the need for surgical mitral valve intervention 8 months after Harpoon Medical device implantation when they developed recurrent mitral regurgitation, (v) and one patient was withdrawn due to the need for surgical mitral valve intervention 9 months after device implant when they developed recurrent mitral regurgitation. One patient completed 2 years follow-up but thereafter moved abroad and did not consent to 5 years follow-up. All other patients completed 5 year clinical and echo follow-up. There were no other serious adverse events recorded during this study, and no serious breaches of protocol.
There were 4 substantial amendments to the protocol during the study: (i) September 25, 2018 –Amendment 2 for change of Chief Investigator, length of the study extended to 3 years, (ii) May 21, 2019 – Amendment 3 for change of Principal Investigator Southampton site, (iii) December 15, 2019 – Amendment 4, length of study extended to 5 years, (iv) September 28, 2020 -SSA exemption Letter: standard of care echocardiogram at satellite site on patients recruited by Southampton General Hospital
There were 4 international original articles emanating from this research study:
1. Gammie JS, Bartus K, Gackowski A, D'Ambra MN, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Moat N, Duncan A, Yadev R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pitterello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P. Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial. J Am Coll Cardiol. 2018 Jan 2;71(1):25-36.2. Talukder S, Duncan A, Moat N. Harpoon Repair for Mitral Regurgitation. CASE: Cardiovascular Imaging Case Reports 2018. CASE: Cardiovascular Imaging Case Reports (Phila). 2019 Feb 3(1):22-24.
3. Gammie JS, Krzysztof B, Gackowski A, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Duncan A, Yadav R, Livesey S, Diprose P, Gerosa G, D’Onofrio A, Pitterello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P, D’Ambra M. Safety and performance of a novel transventricular beating-heart mitral valve repair system: One-year outcomes. Eur J Cardiothorac Surg. 2021;59(1):199-206.
4. Gackowski A, D’Ambra MN, Diprose P, Szymanski P, Duncan A, Bartus K, Gammie JS. Echocardiographic guidance for Harpoon-beating heart mitral valve repair. European Heart Journal - Cardiovascular Imaging 2022;23:294–297
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1985
Date of REC Opinion
19 Jan 2016
REC opinion
Further Information Favourable Opinion