Mitral RegurgitationNCT03988946
Cephea Transseptal Mitral Valve System FIH
A study testing Transcatheter Mitral Valve Replacement via Transseptal Access in people with Mitral Regurgitation, run by Cephea Valve Technologies at 1 site in Australia.
Trial summary
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Transcatheter Mitral Valve Replacement via Transseptal Access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
MVARC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cephea Mitral Valve and Transseptal Delivery System FIH
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
- Conditions
- Mitral Regurgitation
- Being tested
- Transcatheter Mitral Valve Replacement via Transseptal Access
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Mitral Valve Replacement via Transseptal AccessDevice
The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Mitral Valve Replacement | Experimental | Replacement valve delivered through a transfemoral access and transseptal approach Receives: Device: Transcatheter Mitral Valve Replacement via Transseptal Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by freedom from major adverse events
Freedom from major adverse events, including:
- All-cause mortality
- Disabling stroke
- Myocardial infarction
- Renal failure requiring dialysis
- Life-threatening bleeding
- Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Measured: 30 days
Performance
Reduction in mitral regurgitation to ≤1+
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephea Valve Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen J Scotch, Study director, Cephea Valve Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988946
- Sponsor's protocol ID
- CP21549
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cephea Mitral Valve and Transseptal Delivery System FIH
- ClinicalTrials.gov ID
- NCT03988946
- Acronym / sponsor ID
- CP21549
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cephea Valve TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jun 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.
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Mitral Valve Replacement | Experimental | Device: Transcatheter Mitral Valve Replacement via Transseptal AccessReplacement valve delivered through a transfemoral access and transseptal approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Mitral Valve Replacement via Transseptal AccessThe Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment. | Device | Transcatheter Mitral Valve Replacement |
Primary outcome
Safety as measured by freedom from major adverse events
Time frame: 30 days
Freedom from major adverse events, including: * All-cause mortality * Disabling stroke * Myocardial infarction * Renal failure requiring dialysis * Life-threatening bleeding * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Performance
Time frame: 30 days
Reduction in mitral regurgitation to ≤1+
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Helen J Scotch study director
Cephea Valve Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Mitral Valve Replacement via Transseptal Access in people with Mitral Regurgitation, run by Cephea Valve Technologies at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Safety as measured by freedom from major adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 23 Jan 2020.