J-Valve Compassionate Use
Sponsor
JC Medical, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT03876964
Collaborator
(none)
Study Details
Study Description
Brief Summary
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.
Study Design
Study Type:
Expanded Access
Official Title:
J-Valve Compassionate Use Cases
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- JC Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JC Medical, Inc.
ClinicalTrials.gov Identifier:
NCT03876964
Other Study ID Numbers:
- JCU-001
First Posted:
Mar 15, 2019
Last Update Posted:
Mar 15, 2019
Last Verified:
Mar 1, 2019
Additional relevant MeSH terms: