An observational study in AV Block Complete and Tricuspid Regurgitation (TR), sponsored by Deutsches Herzzentrum Muenchen. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Deutsches Herzzentrum Muenchen · Observational
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 25 is below the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Success
The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.
Time frame: 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.
Time frame: at the time of surgery
Safety
Peri- and postprocedural complications associated with pacemaker implantation after TTVR.
Time frame: through study completion (an average of 6 Months)
Type of Pacemaker Implantation
eg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead
Time frame: at the time of surgery
Pacemaker Implantation - Procedural Details
Procedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration.
Time frame: 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.
Time frame: at the time of surgery, through study completion (an average of 6 Months)
Plan to share: Yes
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