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This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System | Device | Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with major adverse events (MAE rates) | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days | 30 days |
| Change in mitral regurgitation severity (scale of 0-4+) by echocardiography | Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity | Discharge: defined as discharge or 7 days post-procedure, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve [MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TMTT Clinical Affairs | Contact | +1 (949) 250 | 2500 | TMTT_Clinical@edwards.com |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Lurz, Prof.Dr.med. | Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien/AKH Wien | Active, not recruiting | Vienna | 1090 | Austria | ||
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| Universitäts-Herzzentrum Freiburg Campus Bad Krozingen |
| Recruiting |
| Bad Krozingen |
| Baden-Wurttemberg |
| 79189 |
| Germany |
|
| Universität Tuebingen | Recruiting | Tübingen | Baden-Wurttemberg | 72074 | Germany |
|
| Uniklinikum Ulm | Active, not recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Uniklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
|
| Medizinische Klinik I- Campus Grosshadern | Recruiting | München | Bavaria | 81377 | Germany |
|
| Immanuel Klinikum Bernau | Active, not recruiting | Bernau bei Berlin | Brandenburg | 16321 | Germany |
| Universitätsklinikum Giessen UKGM | Recruiting | Giessen | Hesse | 35392 | Germany |
|
| Universitaeres Herzzentrum Goettingen | Active, not recruiting | Göttingen | Lower Saxony | 37075 | Germany |
| Westdeutsches Herzzentrum / Uniklinik Essen | Recruiting | Essen | Nordrhine Westfalia | 45122 | Germany |
|
| Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen | Recruiting | Essen | Nordrhine Westfalia | 45138 | Germany |
|
| Herz- und Diabeteszentrum NRW - Bad Oeynhausen | Recruiting | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
|
| Universitätsklinikum Bonn | Recruiting | Bonn | North Rhine-Westphalia | 32545 | Germany |
|
| Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
|
| St.-Johannes-Hospital | Active, not recruiting | Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Universitätsmedizin der Johannes Gutenberg Universität Mainz | Active, not recruiting | Mainz | North Rhine-Westphalia | 55313 | Germany |
| Helios Klinikum Siegburg | Recruiting | Siegburg | North Rhine-Westphalia | 53721 | Germany |
|
| Herzzentrum Universitätsklinik Dresden | Active, not recruiting | Dresden | Saxony | 01307 | Germany |
| Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
|
| Zentralklinik Bad Berka GmbH | Recruiting | Bad Berka | 99438 | Germany |
|
| Charité Berlin | Recruiting | Berlin | 10117 | Germany |
|
| Charité Berlin | Active, not recruiting | Berlin | 13353 | Germany |
| MVZ-CCB | Recruiting | Frankfurt | 60389 | Germany |
|
| Universitares Herzzentrum Hamburg | Recruiting | Hamburg | 20246 | Germany |
|
| Kath. Marienkrankenhaus Hamburg GmbH | Recruiting | Hamburg | 22087 | Germany |
|
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Recruiting | Kiel | 24105 | Germany |
|
| Heart Centre of the University Leipzig | Recruiting | Leipzig | 04289 | Germany |
|
| Hygeia Hospital | Active, not recruiting | Athens | 151 23 | Greece |
| IRCCS Ospedale San Raffaele | Active, not recruiting | Milan | Lombardy | 20132 | Italy |
| Ospedale del Cuore G. Pasquinucci Massa | Active, not recruiting | Massa | 54100 | Italy |
| IRCCS Policlinico San Donato | Active, not recruiting | San Donato Milanese | 20097 | Italy |
| St. Antonius Ziekenhuis | Active, not recruiting | Nieuwegein | 3435 | Netherlands |
| Erasmus MC | Active, not recruiting | Rotterdam | 3015 | Netherlands |
| The Cardinal Stefan Wyszyński, Institute of Cardiology | Active, not recruiting | Warsaw | 04-628 | Poland |
| Hospital Alvaro Cunqueiro | Active, not recruiting | Vigo | 36213 | Spain |
| Inselspital Bern | Active, not recruiting | Bern | 3010 | Switzerland |
| Wythenshawe Hospital | Active, not recruiting | Manchester | M23 9LT | United Kingdom |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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