Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience

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.

Study Overview

• Status: Recruiting
• Conditions: AV Block Complete; Tricuspid Regurgitation (TR)

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Carsten Lennerz, PD Dr. med.; Phone Number: 0049 89 1218 4401; Email: lennerz@dhm.mhn.de

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 80796
      • Recruiting
      • Deutsches Herzzentrum München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.

Description

Inclusion Criteria:

• Transcatheter Tricuspid Valve Replacement

Exclusion Criteria:

• no defined exclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success	The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.	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.	at the time of surgery
Safety	Peri- and postprocedural complications associated with pacemaker implantation after TTVR.	through study completion (an average of 6 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Pacemaker Implantation	eg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead	at the time of surgery
Pacemaker Implantation - Procedural Details	Procedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration.	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.	at the time of surgery, through study completion (an average of 6 Months)

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: GER-EP-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes