Mitral Valve InsufficiencyREPAIRNCT02703311
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
A study testing Cardioband in people with Mitral Valve Insufficiency and Cardiac Valve Annuloplasty, run by Edwards Lifesciences at 10 sites in 3 countries.
Trial summary
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty
- What is being tested?
- Cardioband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- Severe (3+ to 4+) secondary Mitral Regurgitation
- Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
- The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
- Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
- Subject is willing and able to provide informed consent and follow protocol
Who cannot join
- EF < 20%
- LVEDD ≥ 70 mm
- Heavily calcified annulus or leaflets
- Significant CAD requiring revascularization
- Active bacterial endocarditis
- Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
Show all 18Show fewer
- Renal insufficiency requiring dialysis
- Life expectancy of less than twelve months
- Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
- Pulmonary hypertension ≥ 70mmHg at rest
- Mitral valve anatomy which may preclude proper device treatment
- Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
- Severe liver disease
- Patient is pregnant or lactating
- Hypersensitivity to Nickel or Chromium
- Clinically significant bleeding diathesis or coagulopathy
- History of mitral valve repair
- TIA or CVA within 3 months
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany8 sites
Bad Nauheim, Kerckhoff-Klinik
Bad Nauheim, 61231
Bonn University
Bonn
Koln, Universitätsklinikum
Cologne
Universitätsklinikum Gießen und Marburg
Giessen
University Hospital Halle (Saale)
Halle
Asklepios Klinik, St. Georg
Hamburg, 5 20099
Universitäres Herzzentrum Hamburg GmbH
Hamburg
Universitatsmedizin Mainz
Mainz
About this study
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.
Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
- Conditions
- Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Being tested
- Cardioband
- Keywords
- Valtech Cardio, Cardioband, Mitral Valve
- Medical subject headings
- Mitral Valve Insufficiency, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiobandDevice
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
| Study group | Role | What they receive |
|---|---|---|
| Cardioband procedure | Other | Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Receives: Device: Cardioband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Measured: 30 days
Secondary outcomes (2)
Change in Distance Walked on 6 Minute Walk Test
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Measured: 6 months over Baseline
Change in Mitral Regurgitation Severity
Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Measured: 6, 12, and 24 months over baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2017
- Study completionDec 2018
Why it stopped: Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitral Valve 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703311
- Sponsor's protocol ID
- CB1-3
- Acronym
- REPAIR
- Status last verified
- Oct 2020
- First submitted
- 22 Feb 2016
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
- ClinicalTrials.gov ID
- NCT02703311
- Acronym / sponsor ID
- REPAIR / CB1-3
- Conditions
- Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Keywords
- Valtech Cardio, Cardioband, Mitral Valve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 9 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.
Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioband procedure | Other | Device: CardiobandMitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Severe (3+ to 4+) secondary Mitral Regurgitation
- Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
- The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
- Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
Key exclusion criteria (18 listed)
- EF < 20%
- LVEDD ≥ 70 mm
- Heavily calcified annulus or leaflets
- Significant CAD requiring revascularization
- Active bacterial endocarditis
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 |
|---|---|---|
| CardiobandMitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance | Device | Cardioband procedure |
Primary outcome
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Time frame: 30 days
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
2 secondary outcomes
Change in Distance Walked on 6 Minute Walk Test
Time frame: 6 months over Baseline
Change in Mitral Regurgitation Severity
Time frame: 6, 12, and 24 months over baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardioband in people with Mitral Valve Insufficiency and Cardiac Valve Annuloplasty, run by Edwards Lifesciences at 10 sites in 3 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 6 inclusion and 18 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, France, Italy. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. (time frame: 30 days). 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 Nov 2020.