Actively Recruiting
Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated With the Abbott TriClip™ Device in Helios Klinikum Pforzheim
Led by Helios Klinikum Pforzheim · Updated on 2023-09-22
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Significant tricuspid regurgitation (TR) is common in elderly patients and often leads to right heart failure (RHF) with limited treatment options. Surgical intervention carries high risk due to factors like advanced age and organ dysfunction. This observational study aims to assess the safety and performance of the TriClip™ device, a percutaneous treatment designed specifically for TR, in critically ill patients at high or prohibitive surgical risk. Participants will receive a percutaneous edge-to-edge repair of the tricuspid valve using the TriClip system. This single-arm, open-label, prospective registry evaluates real-world outcomes in patients with symptomatic severe TR despite medical therapy. The study follows patients over time to monitor procedural success and clinical benefits of the TriClip device. During the study, participants will be monitored at 12 months for procedural success, changes in quality of life, functional capacity, and major organ system function. The trial collects data on safety and effectiveness in a real-world setting, helping to understand how TriClip therapy impacts patients with right heart failure and tricuspid valve disease over the short and longer term.
CONDITIONS
Brief Title
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Severe tricuspid regurgitation with symptoms despite medical therapy
- Eligible for treatment with the TriClip™ device
- Able and willing to provide written informed consent before the study procedure
You will not qualify if you...
- Participation in another clinical study that could affect the follow-up or results of this study
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.
1 visit (in-person)
Duration - 1 day
Participants undergo percutaneous edge-to-edge repair of the tricuspid valve using the TriClip system.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are observed to evaluate safety, effectiveness, and changes in quality of life, functional capacity, and major organ system function after the procedure.
Periodic visits over 12 months for follow-up assessments
Trial Site Locations
Total: 1 location
1
Helios Klinikum Pforzheim
Pforzheim, Germany, 75175
Actively Recruiting
Research Team
I
Ilka Ott, MD, PhD
A
Alexandru Patrascu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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