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Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.
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| Measure | Description | Time Frame |
|---|---|---|
| Success | The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI. | at the time of surgery |
| Feasibility | Successful pacemaker implantation, regardless of the type of pacemaker, in relation to all patients with a relevant indication following TTVR. | at the time of surgery |
| Safety | Peri- and postprocedural complications associated with pacemaker implantation after TTVR. | through study completion (an average of 6 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Pacemaker Implantation | eg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead | at the time of surgery |
| Pacemaker Implantation - Procedural Details | Procedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carsten Lennerz, PD Dr. med. | Contact | 0049 89 1218 4401 | lennerz@dhm.mhn.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum München | Recruiting | München | Bavaria | 80796 | Germany |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| at the time of surgery |
| Electric Performance | Performance of the electrical pacemaker parameters (e.g. Sensing, Stimulation Threshold, Impedance). Intraoperative measurements and routine device-interrogations in follow-Up. | at the time of surgery, through study completion (an average of 6 Months) |