RecruitingNCT04782232
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
Sponsor
Berlin Heart GmbH
Enrollment
20 participants
Start Date
Jun 1, 2021
Study Type
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria2
- Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
- The contraindications of EXCOR VAD apply.
Interventions
OTHERNo intervention
No intervention due to observational design
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04782232
Related Trials
Mind Your Heart-II
NCT054311921 location
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
NCT06424288652 locations
Timing of Coronary Angiography in NSTEMI Complicated by Acute HF
NCT0700216420 locations
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
NCT06935370641 locations
ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies
NCT071917301 location