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NCT Number: NCT06814574

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement

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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Key information

Conditions

AV Block Complete Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Regurgitation (TR) Tricuspid Valve Insufficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum München

München, Bavaria, 80796, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Transcatheter Tricuspid Valve Replacement

Exclusion criteria

  • no defined exclusion criteria

Treatment and study plan

Primary outcomes

  1. Success

    Time frame: at the time of surgery

    The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.

  2. Feasibility

    Time frame: at the time of surgery

    Successful pacemaker implantation, regardless of the type of pacemaker, in relation to all patients with a relevant indication following TTVR.

  3. Safety

    Time frame: through study completion (an average of 6 Months)

    Peri- and postprocedural complications associated with pacemaker implantation after TTVR.

Secondary outcomes

  1. Type of Pacemaker Implantation

    Time frame: at the time of surgery

    eg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead

  2. Pacemaker Implantation - Procedural Details

    Time frame: at the time of surgery

    Procedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration.

  3. Electric Performance

    Time frame: at 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carsten Lennerz, PD Dr. med.

CONTACT

[email protected]

0049 89 1218 4401

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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