NCT06814574

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 28, 2025

Last Update Submit

February 6, 2025

Conditions

AV Block CompleteTricuspid Regurgitation (TR)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Type of Pacemaker Implantation

    at the time of surgery

  • Pacemaker Implantation - Procedural Details

    at the time of surgery

  • Electric Performance

    at the time of surgery, through study completion (an average of 6 Months)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Transcatheter Tricuspid Valve Replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

München, Bavaria, 80796, Germany

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Carsten Lennerz, PD Dr. med.

CONTACT

0049 89 1218 4401lennerz@dhm.mhn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 7, 2025

Study Start

January 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

DE(1)