Mitral RegurgitationNCT03714412
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
A study testing Implantation in people with Mitral Regurgitation, run by Cardiovalve Ltd. at 2 sites in 2 countries.
Trial summary
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest 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?
- Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2019to 15 Dec 2023
- 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
Who may be able to join
None listed.
Who cannot join
- Cardiovascular Exclusion Criteria
- Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
- Acute myocardial infarction within the previous 30 days
- Any prior heart valve surgery or transcatheter mitral intervention
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
- Rheumatic heart disease or endocarditis within the previous 3 months
Show all 32Show fewer
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
- Untreated clinically significant coronary artery disease requiring revascularization
- Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
- Aortic or pulmonic valve disease requiring surgery
- CRT/ICD implant within 30 days Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
- Left Ventricular Ejection Fraction (LVEF) <30%
- LV end diastolic diameter > 70mm
- Significant abnormalities of the mitral valve and sub-valvular apparatus.
- Severe mitral annular or leaflets calcification
- Left atrial or LV thrombus or vegetation
- Severe right ventricular dysfunction
- Severe tricuspid or aortic valve disease
- General Exclusion Criteria
- Subject who is currently participating in an investigational study, other than this study
- Hemodynamic instability defined as systolic pressure < 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance
- Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications
- Bleeding diathesis or hypercoagulable state
- Active peptic ulcer or active gastrointestinal bleeding
- Pulmonary artery systolic pressure >70 mmHg
- Patients with renal insufficiency (creatinine > 2.5 mg/dL)
- Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months
- Subject with hepatic insufficiency
- Subject has a co-morbid illness that may result in a life expectancy of less than one year
- Active infection that requires antibiotic therapy
- Subject is pregnant, breastfeeding or intend to become pregnant within one year
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.
Read the detailed description
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.
- Conditions
- Mitral Regurgitation
- Being tested
- Implantation
- 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.
ImplantationDevice
Also called Cardiovalve
Implantation of the Cardiovalve transfemoral mitral valve replacement system
| Study group | Role | What they receive |
|---|---|---|
| Implantation | Experimental | Eligible patients will undergo implantation with the Cardiovalve system Receives: Device: Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major device- or procedure- related serious adverse events
Evaluate the safety of the Cardiovalve with its associated procedure
Measured: 30 days
Secondary outcomes (7)
Technical success of delivery and deployment of the device
Technical success of delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis
Measured: Intraoperative
Freedom from emergency surgery or reintervention
Freedom from emergency surgery or reintervention related to the device or access procedure
Measured: 30 days
Freedom from rehospitalizations or reinterventions due to the underlying condition
Freedom from rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, worsening of heart failure)
Measured: 30 days, 3 Months, 6 Months, 12 Months, and 24 Months
Reduction in MR grade
Reduction in MR grade to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) Number of patients with reduction in MR grade from baseline
Measured: 30 days, 3-, 6-, 12 and 24-months
NYHA class
Improvement from baseline in NYHA functional class; Number of patients with improvement in NYHA class
Measured: 30 days, 3-, 6-, 12 and 24-months
6 minute walk test
Increase in distance from baseline
Measured: 30 days, 3-, 6-, 12 and 24-months
Improvement in quality of life from baseline
Improvement from baseline in quality-of-life (Kansas City Cardiomyopathy Questionnaire improvement by ≥ 10)
Measured: 30 days, 3-, 6-, 12 and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study startSep 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Dec 2023 (estimated)
Why it stopped: Amended and merged with AHEAD-EU study
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovalve Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714412
- Sponsor's protocol ID
- CL 008
- Status last verified
- May 2026
- First submitted
- 7 Oct 2018
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System
- ClinicalTrials.gov ID
- NCT03714412
- Acronym / sponsor ID
- CL 008
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Amended and merged with AHEAD-EU study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cardiovalve Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 22 Oct 2018 (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.
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.
Detailed description
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation | Experimental | Device: ImplantationEligible patients will undergo implantation with the Cardiovalve system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- Cardiovascular Exclusion Criteria
- Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
- Acute myocardial infarction within the previous 30 days
- Any prior heart valve surgery or transcatheter mitral intervention
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
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 |
|---|---|---|
| ImplantationAlso: CardiovalveImplantation of the Cardiovalve transfemoral mitral valve replacement system | Device | Implantation |
Primary outcome
Freedom from major device- or procedure- related serious adverse events
Time frame: 30 days
Evaluate the safety of the Cardiovalve with its associated procedure
7 secondary outcomes
Technical success of delivery and deployment of the device
Time frame: Intraoperative
Freedom from emergency surgery or reintervention
Time frame: 30 days
Freedom from rehospitalizations or reinterventions due to the underlying condition
Time frame: 30 days, 3 Months, 6 Months, 12 Months, and 24 Months
Reduction in MR grade
Time frame: 30 days, 3-, 6-, 12 and 24-months
NYHA class
Time frame: 30 days, 3-, 6-, 12 and 24-months
6 minute walk test
Time frame: 30 days, 3-, 6-, 12 and 24-months
Improvement in quality of life from baseline
Time frame: 30 days, 3-, 6-, 12 and 24-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 7 May 2026.
- Individual participant dataSharing planned: No
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Mitral Regurgitation (MR)
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation in people with Mitral Regurgitation, run by Cardiovalve Ltd. at 2 sites in 2 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 0 inclusion and 32 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Poland. 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 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 device- or procedure- related serious adverse events (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 7 May 2026.