Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable device | Experimental | WATCHMAN LAA Closure Technology (Gen 4.0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN LAA Closure Technology (Gen 4.0) | Device | Implantation of the WATCHMAN device into the left atrial appendage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure. | The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure. | 12-Months |
| Device Success | Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary. | Implant through 45-Days |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Na Homolce Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NA Homolce Hospital | Prague | 150 30 | Czechia | |||
| Krankenhaus der Barmherzige Bruder |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Regensburg |
| Bavaria |
| 93049 |
| Germany |
| Sankt Katharinen Hospital / Cardiovasculares Centrum | Frankfurt | 60389 | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |