Back to resultsJ-Valve Compassionate Use
Primary Purpose
Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Transcatheter Aortic Valve Replacement
Sponsored by
About this trial
This is an expanded access trial for Aortic Valve Disease
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03876964
Brief Title
J-Valve Compassionate Use
Official Title
J-Valve Compassionate Use Cases
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JC Medical, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Transcatheter Aortic Valve Replacement
Other Intervention Name(s)
TAVR
Intervention Description
Minimally invasive replacement of the aortic valve through a catheter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis M McMahon, MD
Phone
650-477-2781
Ext
7601
Email
dmcmahon@jcmedicalinc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Yang, PhD
Phone
650-477-2781
Email
cyang@jcmedicalinc.com
12. IPD Sharing Statement
Learn more about this trial
J-Valve Compassionate Use
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