Registry for outcomes of percutaneous tricuspid valve repair
Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated With the Abbott TriClip™ Device in Helios Klinikum Pforzheim
Helios Klinikum Pforzheim · NCT05179616
This study is testing how well the TriClip™ device works for treating severe tricuspid regurgitation in critically ill patients who still have symptoms despite taking medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helios Klinikum Pforzheim (other) |
| Locations | 1 site (Pforzheim) |
| Trial ID | NCT05179616 on ClinicalTrials.gov |
What this trial studies
The Pforzheim Tricuspid Valve Registry aims to evaluate the safety and effectiveness of the TriClip™ device in treating severe tricuspid regurgitation in critically ill patients. This observational study is conducted in a single-center, open-label format, focusing on patients who are symptomatic despite medical therapy. The registry will collect data on patient outcomes following the transcatheter edge-to-edge tricuspid valve repair procedure, providing insights into its real-world application and performance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with severe tricuspid regurgitation who remain symptomatic despite medical therapy.
Not a fit: Patients who are participating in another clinical study that may affect the outcomes of this registry will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option for patients suffering from severe tricuspid regurgitation and improve their quality of life.
How similar studies have performed: Other studies have shown promising results with similar percutaneous approaches for treating tricuspid regurgitation, but this specific registry focuses on the newly approved TriClip™ device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy. * Subjects eligible to receive the TriClip™ * Subjects must provide written informed consent prior to study procedure. Exclusion Criteria: * Subjects participating in another clinical study that may impact the follow-up or results of this study.
Where this trial is running
Pforzheim
- Helios Klinikum Pforzheim — Pforzheim, Germany (RECRUITING)
Study contacts
- Principal investigator: Ilka Ott, MD, PhD — Helios Klinikum Pforzheim
- Study coordinator: Ilka Ott, MD, PhD
- Email: Ilka.Ott@helios-pforzheim.de
- Phone: +4972319692955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial