J-Valve Compassionate Use

JC Medical

Status

Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Insufficiency

Treatments: Device: Transcatheter Aortic Valve Replacement

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03876964

JCU-001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria