Registry to evaluate the safety of a new venous cannula for patients with heart failure
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
This study is testing the safety of a new venous cannula for patients with heart failure who are using a special heart pump to see how well it works and if it has any risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Berlin Heart GmbH Industry-sponsored |
| Locations | 1 site (Munich) |
| Trial ID | NCT04782232 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to monitor the clinical safety and performance of the EXCOR Venous Cannula used in conjunction with EXCOR Ventricular Assist Device (VAD) therapy. The study will assess both short- and long-term clinical improvements while identifying and managing potential risks associated with the device. Conducted over 42 months, it includes an enrollment period of 28 months and follow-up of up to 12 months across multiple international centers.
Who should consider this trial
Good fit: Ideal candidates include patients with heart failure who are on a transplant list or eligible for heart transplantation and have a body surface area of at least 1.2 m².
Not a fit: Patients who do not meet the eligibility criteria for the EXCOR VAD or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of heart failure treatments for patients with complex cardiac conditions.
How similar studies have performed: While this approach is observational and builds on existing technologies, similar studies have shown promise in improving outcomes for patients with heart failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form, * The indications on RVAD and BVAD use of the EXCOR VAD apply, * Patient shall be on transplant list or at least eligible for HTx, * BSA (body surface area) greater than or equal to 1.2 m². Exclusion Criteria: * Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent, * The contraindications of EXCOR VAD apply.
Where this trial is running
Munich
- LMU Klinikum — Munich, Germany (Recruiting)
Study contacts
- Study coordinator: Thomas Schöndorf, Dr. Dr. PD
- Email: clinical.science@berlinheart.de
- Phone: +49 30 81872600
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.