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
RegiVe
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 17, 2025
August 1, 2024
6.3 years
February 15, 2021
February 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Rate of mortality
Short-term mortality
30 days
Rate of major bleeding
Short-term rate of major bleeding
30 days
Rate of thrombosis
Short-term rate of thrombosis
30 days
Survival to heart transplantation
Long-term survival to heart transplantation
up to 12 months
Secondary Outcomes (1)
Rate of adverse events
up to 12 months
Study Arms (1)
Patients with failing/absence of the right heart
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.
Interventions
No intervention due to observational design
Eligibility Criteria
Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.
You may qualify if:
- 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.
You may not qualify if:
- Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
- The contraindications of EXCOR VAD apply.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LMU Klinikum
Munich, Germany
Related Publications (1)
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: 36368697DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2021
First Posted
March 4, 2021
Study Start
June 1, 2021
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 17, 2025
Record last verified: 2024-08