Aortic Valve DiseaseNCT03876964
J-Valve Compassionate Use
A study testing Transcatheter Aortic Valve Replacement in people with Aortic Valve Disease and Aortic Valve Insufficiency, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC.
Trial summary
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
About this study
Official title: J-Valve Compassionate Use Cases
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
Read the 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.
- Being tested
- Transcatheter Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementDevice
Also called TAVR
Minimally invasive replacement of the aortic valve through a catheter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876964
- Sponsor's protocol ID
- JCU-001
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2019
- Last updated
- 11 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- J-Valve Compassionate Use Cases
- ClinicalTrials.gov ID
- NCT03876964
- Acronym / sponsor ID
- JCU-001
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLCIndustry (pharma, biotech, devices)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ReplacementAlso: TAVRMinimally invasive replacement of the aortic valve through a catheter. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Replacement in people with Aortic Valve Disease and Aortic Valve Insufficiency, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.