Mitral InsufficiencyNCT02478008
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
A study testing CardiAQ TMVI System (Transapical DS) in people with Mitral Insufficiency and Heart Valve Disease, run by Edwards Lifesciences at 9 sites in 4 countries.
Trial summary
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease
- What is being tested?
- CardiAQ TMVI System (Transapical DS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jun 2015to Aug 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- NYHA Classification ≥ III
- Left Ventricular Ejection Fraction ≥ 30%
- Mitral regurgitation ≥ Grade 3+
- Subject meets anatomical eligibility criteria for the investigational device
Who cannot join
None listed.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France3 sites
Centre hospitalier régional universitaire de Lille
Lille
Hôpital Européen Georges-Pompidou
Paris
Centre Hospitalier Universiatier de Toulouse
Toulouse
Netherlands3 sites
Medisch Centrum Leeuwarden
Leeuwarden
St. Antonius Ziekenhuis
Nieuwegein
Erasmus University Medical Center
Rotterdam
United Kingdom2 sites
Leeds General Infirmary
Leeds
New Cross Hospital Heart Center
Wolverhampton
About this study
Official title: A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
- Being tested
- CardiAQ TMVI System (Transapical DS)
- Keywords
- Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical
- Medical subject headings
- Mitral Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiAQ TMVI System (Transapical DS)Device
| Study group | Role | What they receive |
|---|---|---|
| CardiAQ TMVI System (Transapical DS) | Experimental | Not described Receives: Device: CardiAQ TMVI System (Transapical DS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Major Adverse Event Rate
Measured: 30-Day
Composite Major Adverse Event Rate
Measured: 12-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Søndergaard, MD, DMSc, Principal investigator, Rigshospitalet University Hospital (Copenhagen, Denmark)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478008
- Sponsor's protocol ID
- CIP-3102-01
- Status last verified
- Sep 2015
- First submitted
- 17 Jun 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
- ClinicalTrials.gov ID
- NCT02478008
- Acronym / sponsor ID
- CIP-3102-01
- Keywords
- Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardiAQ TMVI System (Transapical DS) | Experimental | Device: CardiAQ TMVI System (Transapical DS) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- NYHA Classification ≥ III
- Left Ventricular Ejection Fraction ≥ 30%
- Mitral regurgitation ≥ Grade 3+
- Subject meets anatomical eligibility criteria for the investigational device
Key exclusion criteria (0 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 |
|---|---|---|
| CardiAQ TMVI System (Transapical DS) | Device | CardiAQ TMVI System (Transapical DS) |
Primary outcome
Composite Major Adverse Event Rate
Time frame: 30-Day
Composite Major Adverse Event Rate
Time frame: 12-Month
Results and safety
The study was stopped early (reason given: Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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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.
Lars Søndergaard, MD, DMSc principal investigator
Rigshospitalet University Hospital (Copenhagen, Denmark)
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardiAQ TMVI System (Transapical DS) in people with Mitral Insufficiency and Heart Valve Disease, run by Edwards Lifesciences at 9 sites in 4 countries.
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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Netherlands, United Kingdom, Denmark. 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 was stopped early (reason given: Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur.). 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.
What does the primary outcome measure?
Composite Major Adverse Event Rate (time frame: 30-Day). 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 31 Mar 2016.