Left Atrial Appendage Closure, Non-valvular Atrial Fibrillation (AF)
Conditions
Keywords
LAAC
Brief summary
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.
Interventions
DEVICELeft atrial appendage closure
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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device. 2. Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU). 3. Subject or legal representative who are willing and capable of providing informed consent. 4. Subject is able and willing to return for required follow-up visits and examinations. 5. Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. Subject has a documented life expectancy of less than 12 months. 2. Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. 3. Intracardiac thrombus is present. 4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. 5. The LAA anatomy will not accommodate a Closure Device. 6. Subject has a known hypersensitivity or contraindications according to IFU. 7. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a safety event treated with the WATCHMAN FLX Pro | Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later | 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. |
| Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution | Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later | 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 |
| Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment | Completion of transseptal puncture | VersaCross Connect™ LAAC Access Solution acute procedural success: Acute Procedural Success is defined as transseptal puncture success (VersaCross RF-wire crossing into left atrium). |
Countries
Denmark, Germany, Italy, Poland, Spain, Switzerland
Contacts
CONTACTThomas Näschen, PhD
PRINCIPAL_INVESTIGATORMarek Grygier, Prof. MD, PHD
Uniwersytecki Szpital Kliniczny w Poznaniu
PRINCIPAL_INVESTIGATORArian Sultan, Prof. MD
Asklepios Klinik Saint Georg
Outcome results
None listed