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The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connect™ LAAC Access Solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WATCHMAN FLX Pro | This arm is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. Approximately 300 patients undergo the LAAC procedure in conjunction with the use of the VersaCross Connect™ LAAC Access Solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial appendage closure | Device | The WATCHMAN FLX Pro LAAC Technology is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in adult patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy. The VersaCross Connect™ LAAC Access Solution is indicated for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a safety event treated with the WATCHMAN FLX Pro | Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and minor nonsurgical treatments of access site complications are excluded from this endpoint. | Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later |
| Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution | Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: For all enrolled subjects, who had an attempt to insert the VersaCross Connect™ LAAC Access Solution device, the composite rate of all-cause death, all stroke, systemic embolism, pericardial effusion resulting in interventions*, and ISTH major bleeding. *Pericardial effusion/tamponade requiring pericardiocentesis or surgery to treat | Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later |
| Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment | VersaCross Connect™ LAAC Access Solution acute procedural success: Acute Procedural Success is defined as transseptal puncture success (VersaCross RF-wire crossing into left atrium). | Completion of transseptal puncture |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Näschen, PhD | Contact | +491707828594 | Thomas.Naeschen@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Marek Grygier, Prof. MD, PHD | Uniwersytecki Szpital Kliniczny w Poznaniu | Principal Investigator |
| Arian Sultan, Prof. MD | Asklepios Klinik Saint Georg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Rigshospitalet Copenhagen | Recruiting | Copenhagen | 2100 | Denmark |
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| Kath Krankenhaus St Johann Nepomuk | Recruiting | Erfurt | 99097 | Germany |
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| Asklepios Klinik Saint Georg | Recruiting | Hamburg | 20099 | Germany |
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| Asklepios Klinik Nord Heidberg | Recruiting | Hamburg | 22417 | Germany |
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| Asklepios Klinik Altona | Recruiting | Hamburg | 22763 | Germany |
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| Centro Cardiologico Monzino | Recruiting | Milan | 20138 | Italy |
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| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | 61-848 | Poland |
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| Hospital de Leon | Recruiting | León | 24071 | Spain |
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| Clinica Universidad de Navarra | Recruiting | Pamplona | 31008 | Spain |
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| Complejo Hospitalario Universitario de Pontevedra | Recruiting | Pontevedra | 36001 | Spain |
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| Hospital Clinico Salamanca | Recruiting | Salamanca | 37007 | Spain |
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| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| INSELSPITAL - Universitätsspital Bern | Recruiting | Bern | CH-3010 | Switzerland |
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