Observational registry for heart failure treatment with IASD System II
A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
This study is collecting information from patients in Germany who are using the IASD System II device for heart failure to see how well it works and how it affects their quality of life in everyday situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Corvia Medical Industry-sponsored |
| Locations | 27 sites (Bad Nauheim and 26 other locations) |
| Trial ID | NCT03191656 on ClinicalTrials.gov |
What this trial studies
This observational registry collects post-market data on patients treated with the IASD System II, a device approved in the EU for heart failure. Conducted at multiple sites in Germany, the study aims to evaluate the efficacy, safety, and quality of life outcomes associated with this new treatment in a real-world clinical setting. By documenting the experiences of consecutive patients, the registry seeks to provide valuable insights into the device's performance outside of controlled trial conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with heart failure who are being treated with the IASD System II.
Not a fit: Patients who are not receiving the IASD System II implant or those with contraindications to the device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options and improve quality of life for patients with heart failure.
How similar studies have performed: Other studies involving similar devices for heart failure have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
This is a post market registry so no criteria requirements (only recommendations).
Where this trial is running
Bad Nauheim and 26 other locations
- Herzzentrum der Kerckhoff-Klinik — Bad Nauheim, Germany (Recruiting)
- Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie — Bad Oeynhausen, Germany (Recruiting)
- Segeberger Kliniken GmbH — Bad Segeberg, Germany (Recruiting)
- Unfallkrankenhaus Berlin — Berlin, Germany (Recruiting)
- Klinikum Chemnitz gGmbH — Chemnitz, Germany (Recruiting)
- Klinikum Lippe GmbH — Detmold, Germany (Terminated)
- Herzzentrum Dresden GmbH — Dresden, Germany (Recruiting)
- Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie — Düsseldorf, Germany (Recruiting)
- Elisabeth-Krankenhaus Essen — Essen, Germany (Terminated)
- Universitätsklinikum Gießen — Giessen, Germany (Recruiting)
- Universitätsklinikum Göttingen — Göttingen, Germany (Recruiting)
- Universitäts Klinikum Halle — Halle, Germany (Recruiting)
- Klinikum am Plattenwald Bad Friedrichshall — Heilbronn, Germany (Terminated)
- Klinikum Karlsburg — Karlsburg, Germany (Recruiting)
- Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische — Kiel, Germany (Terminated)
- Herzzentrum der Universität zu Köln — Köln, Germany (Recruiting)
- Klinikum Sankt Georg — Leipzig, Germany (Terminated)
- Universitätsklinikum Schleswig-Holstein — Lübeck, Germany (Recruiting)
- Universitätsklinikum Munster — Münster, Germany (Recruiting)
- Niels-Stensen-Kliniken - Marienhospital — Osnabrück, Germany (Terminated)
- St Vincenz-Kranenhaus — Paderborn, Germany (Terminated)
- Herz-Kreislauf-Zentrum Rotenburg — Rotenburg, Germany (Terminated)
- Helios Kliniken Schwerin — Schwerin, Germany (Recruiting)
- Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation — Wittenberg, Germany (Recruiting)
- Heinrich Braun Klinikum — Zwickaü, Germany (Recruiting)
- Universitätsklinik Ulm-Keßler — Ülm, Germany (Recruiting)
- Bürgelspital Solothurn — Solothurn, Switzerland (Recruiting)
Study contacts
- Study coordinator: Jan Komtebedde, DVM
- Email: jkomtebedde@corviamedical.com
- Phone: 978-654-6113
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.