Actively Recruiting
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience
Led by Deutsches Herzzentrum Muenchen · Updated on 2025-02-07
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients who have undergone transcatheter tricuspid valve replacement (TTVR), a procedure linked with a high risk of developing third-degree atrioventricular block (AVB). The study aims to find the best method for pacemaker implantation to manage this risk effectively. It is an observational study conducted to understand the optimal therapeutic approach for pacemaker use after TTVR. Participants in this study have received TTVR and are monitored for pacemaker implantation. The study evaluates the success, feasibility, and safety of pacemaker implantation at the time of surgery and follows participants for an average of six months to assess ongoing electric performance and procedural details related to the pacemaker. During the study, participants will be closely observed through surgery and follow-up visits over approximately six months. Researchers will assess the safety and effectiveness of the pacemaker implantation, including the type of pacemaker used and its electrical functioning. The overall goal is to improve management strategies for patients requiring pacemakers after TTVR.
CONDITIONS
Brief Title
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have undergone transcatheter tricuspid valve replacement
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At the time of surgery
Participants undergo pacemaker implantation following transcatheter tricuspid valve replacement and are monitored for procedural success and safety.
1 visit (in-person)
Duration - Approximately 6 months
Participants are monitored for pacemaker performance and safety through study completion.
Regular follow-up visits during this period
Trial Site Locations
Total: 1 location
1
Deutsches Herzzentrum München
München, Bavaria, Germany, 80796
Actively Recruiting
Research Team
C
Carsten Lennerz, PD Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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