NCT04782232 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
| NCT ID | NCT04782232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Berlin Heart GmbH |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2021-06-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04782232 clinical trial?
This trial is open to participants of all sexes, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04782232 currently recruiting?
Yes, NCT04782232 is actively recruiting participants. Contact the research team at clinical.science@berlinheart.de for enrollment information.
Where is the NCT04782232 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT04782232 clinical trial?
NCT04782232 is sponsored by Berlin Heart GmbH. The trial plans to enroll 20 participants.
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