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NCT03876964 Clinical Trial

J-Valve Compassionate Use

Aortic Valve Stenosis Clinical Trial

Official title:
J-Valve Compassionate Use Cases

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03876964
Other study ID # JCU-001
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date April 2023
Source JC Medical, Inc.
Contact Dennis M McMahon, MD
Phone 650-477-2781
Email dmcmahon@jcmedicalinc.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transcatheter Aortic Valve Replacement
Minimally invasive replacement of the aortic valve through a catheter.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
JC Medical, Inc.
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