Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorDeutsches Herzzentrum Muenchen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Transcatheter Tricuspid Valve Replacement
Disqualifiers
no defined exclusion criteria
Trial population
The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 surgery2
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 surgery3
Safety
Peri- and postprocedural complications associated with pacemaker implantation after TTVR.
Time frame
through study completion (an average of 6 Months)Secondary outcomes
1
Type of Pacemaker Implantation
eg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead
Time frame
at the time of surgery2
Pacemaker Implantation - Procedural Details
Procedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration.
Time frame
at the time of surgery3
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)Sponsors and contacts
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Source ClinicalTrials.gov