To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
This trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study that will evaluate subjects for up to 5 years post treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Repair of the chordae tendinae in the mitral valve.
Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
Innsbruck, Tyrol, Austria
Kepler Universitätsklinikum GmbH
Linz, Upper Austria, Austria
Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, Germany
Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding
Subject's freedom from all-cause mortality, disabling stroke and life-threatening bleeding at 30 days post-implant.
Time frame: 30 days
Number of Subjects With Procedural Success During the First 30 Days
Subject's procedural success at 30 days post-treatment, as measured by: Technical success (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.
Time frame: 30 days
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Rhön Klinikum Kardiochirurgie
Bad Neustadt an der Saale, Bavaria, Germany
Kerckhoff Klinik GmbH
Bad Nauheim, Hesse, Germany
Schüchtermann Klinik
Bad Rothenfelde, Lower Saxony, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals
London, United Kingdom