Brief Title
J-Valve Compassionate Use
Official Title
J-Valve Compassionate Use Cases
Brief Summary
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
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 Type
Expanded Access
Condition
Aortic Valve Disease
Intervention
Transcatheter Aortic Valve Replacement
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Gender
All
Ages
18 Years - N/A
Contacts
, 650-477-2781, [email protected]
Administrative Informations
NCT ID
NCT03876964
Organization ID
JCU-001
Responsible Party
Sponsor
Study Sponsor
JC Medical, Inc.
Study Sponsor
, ,
Verification Date
March 2019