Registry for outcomes of percutaneous tricuspid valve repair
Official title: Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated With the Abbott TriClip™ Device in Helios Klinikum Pforzheim
Run by Helios Klinikum Pforzheim · NCT05179616 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Helios Klinikum Pforzheim Academic / other |
| Locations | 1 site (Pforzheim) |
| Status | Recruiting |
| Started | November 30, 2020 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2026 |
| Registry record updated | September 22, 2023 |
| Trial ID | NCT05179616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with severe tricuspid regurgitation who remain symptomatic despite medical therapy.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
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CorVad Percutaneous Ventricular Assist System for Refractory Right Heart Failure
This trial tests whether the CorVad percutaneous ventricular assist device can be safely used to help patients with stubborn right heart failure when medicines and support devices aren’t enough.
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Compare leadless and left bundle branch pacemakers for heart and valve function
This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.
-
TriClip for treating tricuspid regurgitation in Japan
This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.
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Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults
This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
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Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation
This project will follow adults with ARDS on mechanical ventilation to see how positive‑pressure breathing affects the right heart over time and how that relates to circulation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.