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J-Valve Compassionate Use

NCT ID: NCT03876964

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

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Detailed Description

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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.

Conditions

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Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis

Interventions

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Transcatheter Aortic Valve Replacement

Minimally invasive replacement of the aortic valve through a catheter.

Intervention Type DEVICE

Other Intervention Names

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TAVR

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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JCU-001

Identifier Type: -

Identifier Source: org_study_id

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