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Recruiting NCT06814574

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement

— Observational AV Block Complete Tricuspid Regurgitation (TR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: AV Block Complete, Tricuspid Regurgitation (TR). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience

Overview

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.

Primary outcome measures

  • Success [Time frame: at the time of surgery]
  • Feasibility [Time frame: at the time of surgery]
  • Safety [Time frame: through study completion (an average of 6 Months)]
Secondary outcome measures (3)
  • Type of Pacemaker Implantation [Time frame: at the time of surgery]
  • Pacemaker Implantation - Procedural Details [Time frame: at the time of surgery]
  • Electric Performance [Time frame: at the time of surgery, through study completion (an average of 6 Months)]

Eligibility criteria

Inclusion criteria

  • Transcatheter Tricuspid Valve Replacement

Exclusion criteria

  • no defined exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Deutsches Herzzentrum München — München

Identifiers

NCT: NCT06814574 · GER-EP-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗