Mitral Valve RegurgitationPhase 1/2RELIEFNCT02722551
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
A Phase 1/2 study testing Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve in people with Mitral Valve Regurgitation, run by Edwards Lifesciences at 15 sites in 7 countries.
Trial summary
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Nov 2016to Oct 2024
- Phase
- Phase 1/2
- 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
Who may be able to join
- NYHA ≥ II
- Moderate/severe or severe mitral regurgitation
- Prohibitive risk for open-heart surgery
- Meets anatomical criteria
Who cannot join
- Unsuitable anatomy
- Need for emergent or urgent surgery
- Prior mechanical aortic valve replacement
- Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
- Preexisting device in the left ventricular apex
- Clinically significant, untreated coronary artery disease
- Limited life expectancy (< 12 months)
- Active infection
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
Germany5 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Deutsche Herzzentrum Berlin
Berlin, 13353
Herzzentrum der UniKlinik Köln
Cologne, 50937
University Heart Centre
Hamburg, 20146
Leipzig Herzzentrum
Leipzig, 04289
Canada4 sites
Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Québec, G1V 4G5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Centre Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Paul's Hospital, University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
Italy2 sites
Ospedale San Raffaele
Milan, 20132
Universita di Roma Tor Vergata
Roma, 00133
About this study
Official title: The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
Read the detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
- Keywords
- Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart valve, Mitral valve, Transapical, Transfemoral, Transeptal, Severe
- Medical subject headings
- Mitral Valve Insufficiency, Gastroesophageal Reflux, Neoplasm Metastasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral ValveDevice
Replacement of the mitral valve through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery) Receives: Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse cardiac and cerebrovascular events
MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions
Measured: 30 days
Freedom from individual adverse events
% Freedom from individual adverse events
Measured: 30 days
Secondary outcomes (7)
New York Heart Association (NYHA) functional class
Number of patients with improvement in NYHA class
Measured: 30 days, 3 months, 6 months, 12 months
Six minute walk test:
Increase in distance (m) from baseline
Measured: 30 days, 3 months, 6 months, 12 months
Reduction in mitral regurgitation (MR) grade:
Number of patients with reduction in MR grade from baseline
Measured: 30 days, 3 months, 6 months, 12 months
Technical success
Technical success per MVARC criteria (%)
Measured: 30 days, 3 months, 6 months, 12 months
Device success
Device success per MVARC criteria (%)
Measured: 30 days, 3 months, 6 months, 12 months
Procedure success
Procedure success per MVARC criteria (%)
Measured: 30 days, 3 months, 6 months, 12 months
Patient success
Patient success per MVARC criteria (%)
Measured: 30 days, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Sondergaard, Principal investigator, The Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722551
- Sponsor's protocol ID
- 2015-14
- Acronym
- RELIEF
- Status last verified
- Jan 2018
- First submitted
- 1 Mar 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve
- ClinicalTrials.gov ID
- NCT02722551
- Acronym / sponsor ID
- RELIEF / 2015-14
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 30 Mar 2016 (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.
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
Detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral ValveTreatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NYHA ≥ II
- Moderate/severe or severe mitral regurgitation
- Prohibitive risk for open-heart surgery
- Meets anatomical criteria
Key exclusion criteria (8 listed)
- Unsuitable anatomy
- Need for emergent or urgent surgery
- Prior mechanical aortic valve replacement
- Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
- Preexisting device in the left ventricular apex
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 Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral ValveReplacement of the mitral valve through a transcatheter approach | Device | Treatment |
Primary outcome
Freedom from major adverse cardiac and cerebrovascular events
Time frame: 30 days
MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions
Freedom from individual adverse events
Time frame: 30 days
% Freedom from individual adverse events
7 secondary outcomes
New York Heart Association (NYHA) functional class
Time frame: 30 days, 3 months, 6 months, 12 months
Six minute walk test:
Time frame: 30 days, 3 months, 6 months, 12 months
Reduction in mitral regurgitation (MR) grade:
Time frame: 30 days, 3 months, 6 months, 12 months
Technical success
Time frame: 30 days, 3 months, 6 months, 12 months
Device success
Time frame: 30 days, 3 months, 6 months, 12 months
Procedure success
Time frame: 30 days, 3 months, 6 months, 12 months
Patient success
Time frame: 30 days, 3 months, 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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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 Sondergaard principal investigator
The Rigshospitalet, Copenhagen, Denmark
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve in people with Mitral Valve Regurgitation, run by Edwards Lifesciences at 15 sites in 7 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 8 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: withdrawn, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Canada, Italy, Denmark, France and 2 more countries. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Freedom from major adverse cardiac and cerebrovascular 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 9 Jan 2018.