An observational study in Heart Failure, Univentricular Heart and Ventricular Dysfunction, sponsored by Berlin Heart GmbH. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Berlin Heart GmbH · Observational
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.
The registry study has an observational, prospective, international, multi-center, non-randomized design.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 20 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Berlin Heart GmbH is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support.
Other: No intervention
No intervention due to observational design
Rate of mortality
Short-term mortality
Time frame: 30 days
Rate of major bleeding
Short-term rate of major bleeding
Time frame: 30 days
Rate of thrombosis
Short-term rate of thrombosis
Time frame: 30 days
Survival to heart transplantation
Long-term survival to heart transplantation
Time frame: up to 12 months
Rate of adverse events
Safety of the device
Time frame: up to 12 months
Started Jun 2021 (actual). Primary completion is estimated for Sep 2027, 75 months after the start.
Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's planned 75 months is above that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Berlin Heart GmbH