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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Other No intervention
No intervention due to observational design
Primary outcome measures
- Rate of mortality [Time frame: 30 days]
- Rate of major bleeding [Time frame: 30 days]
- Rate of thrombosis [Time frame: 30 days]
- Survival to heart transplantation [Time frame: up to 12 months]
Secondary outcome measures (1)
- Rate of adverse events [Time frame: up to 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- LMU Klinikum — Munich
Publications
- Dal Sasso E, Schondorf T, Schluter KJ, Miera O, De Rita F, Menon AK; European EXCOR(R) Pediatric Investigator Group (EEPIG). A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients. Thorac Cardiovasc Surg. 2022 Dec;70(S 03):e34-e41. doi: 10.1055/s-0042-1757916. Epub 2022 Nov 11. PMID 36368697
Identifiers
NCT: NCT04782232 · E-20-325