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Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06814574
Enrollment
25
Registered
2025-02-07
Start date
2024-01-01
Completion date
2025-01-31
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AV Block Complete, Tricuspid Regurgitation (TR)

Brief summary

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.

Interventions

None listed

Sponsors

Deutsches Herzzentrum Muenchen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Transcatheter Tricuspid Valve Replacement

Exclusion criteria

* no defined

Design outcomes

Primary

MeasureTime frameDescription
Successat the time of surgeryThe number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.
Feasibilityat the time of surgerySuccessful pacemaker implantation, regardless of the type of pacemaker, in relation to all patients with a relevant indication following TTVR.
Safetythrough study completion (an average of 6 Months)Peri- and postprocedural complications associated with pacemaker implantation after TTVR.

Secondary

MeasureTime frameDescription
Type of Pacemaker Implantationat the time of surgeryeg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead
Pacemaker Implantation - Procedural Detailsat the time of surgeryProcedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration.
Electric Performanceat the time of surgery, through study completion (an average of 6 Months)Performance of the electrical pacemaker parameters (e.g. Sensing, Stimulation Threshold, Impedance). Intraoperative measurements and routine device-interrogations in follow-Up.

Countries

Germany

Contacts

Primary ContactCarsten Lennerz, PD Dr. med.
lennerz@dhm.mhn.de0049 89 1218 4401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026