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| Name | Class |
|---|---|
| Osypka AG | UNKNOWN |
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Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery.
The DefiPace registry is designed in two phases
Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery)
Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A | Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery)
|
| |
| Phase B | Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of POAF | Incidence of POAF | 30 days |
| Termination of POAF | Termination of POAF | 30 days |
| Time in POAF | Time in POAF (AF Burden) | 30 days |
| Time to cardioversion | Median time to cardioversion | 30 days |
| Number of shocks | Mean number of shocks per patient | 30 days |
| Energy requirements | Mean energy requirements (first/subsequent) | 30 days |
| POAF recurrence | POAF recurrence/repeat cardioversions | 30 days |
| Time in ICU | Time in ICU in hours | 30 days |
| Procedural success | Procedural success | 30 days |
| Time needed for electrode placement |
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Inclusion Criteria:
Exclusion Criteria:
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Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Nitz, PhD | Contact | +49 447185033 | 27 | susanne.nitz@ippmed.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter Bramlage, Professor | IPPMed | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12683560 | Background | Bechtel JF, Christiansen JF, Sievers HH, Bartels C. Low-energy cardioversion versus medical treatment for the termination of atrial fibrillation after CABG. Ann Thorac Surg. 2003 Apr;75(4):1185-8. doi: 10.1016/s0003-4975(02)04715-x. | |
| 9738643 | Background | Liebold A, Wahba A, Birnbaum DE. Low-energy cardioversion with epicardial wire electrodes: new treatment of atrial fibrillation after open heart surgery. Circulation. 1998 Sep 1;98(9):883-6. doi: 10.1161/01.cir.98.9.883. |
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Time needed for electrode placement |
| 30 days |
| Universitätsklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
|
| Klinikum Nürnberg | Recruiting | Nuremberg | Bavaria | 90419 | Germany |
|
| University Hospital of Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
|
| Oldenburg Hospital AöR / Medical Campus University of Oldenburg | Recruiting | Oldenburg | Lower Saxony | 26133 | Germany |
|
| Heart Center Dresden GmbH University Hospital | Recruiting | Dresden | Saxony | 01307 | Germany |
|
| Albert-Ludwigs-Universitaet Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
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| Hannover Medical School | Recruiting | Hanover | 30625 | Germany |
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| University Hospital Jena | Recruiting | Jena | 07747 | Germany |
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| University Hospital Ulm | Recruiting | Ulm | 89081 | Germany |
|