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J-Valve Compassionate Use

J-Valve Compassionate Use Cases

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03876964
Enrollment
Unknown
Registered
2019-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis

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.

Interventions

DEVICETranscatheter Aortic Valve Replacement

Minimally invasive replacement of the aortic valve through a catheter.

Sponsors

JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

\-

Exclusion criteria

\-

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026