Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-13-09-011614 | Other Identifier | EUDAMED |
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 is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAA closure device | Experimental | Implantation of LAA closure device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of LAA closure device | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications. | A major complication is defined as an event that results in death, procedure related stroke, systemic embolism, device embolisation, pericardial effusion (cardiac tamponade), or other major bleeding requiring invasive treatment or blood transfusions. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johannes Brachmann, Prof | Klinikum Coburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | Germany | ||||
| Kardiologie Universitätsklinikum Bonn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bonn |
| Germany |
| Medizinische Klinikum Coburg | Coburg | 96450 | Germany |
| CardioVascular Center Frankfurt | Frankfurt | Germany |
| Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH | Leipzig | Germany |
| University Medical Center of Johannes Gutenberg-University Mainz | Mainz | Germany |
| NHS Trust (ICHNT) Hammersmith Hospital London | London | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided