Mitral RegurgitationNCT03958773
Cardiovalve Transfemoral System - FIM Study
A study testing Cardiovalve transfemoral Mitral valve system in people with Mitral Regurgitation, run by Cardiovalve Ltd. at 1 site in Lithuania.
Trial summary
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible. 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?
- Cardiovalve transfemoral Mitral valve system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLithuania
- Study dates
- 12 Oct 2017to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- NYHA functional II, III or ambulatory IV
- Severe mitral regurgitation (MR grade 3-4+)
- High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum)
- Able to undergo Transesophageal Echocardiography (TEE).
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
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- The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
- Suitable for femoral access procedure and transseptal catheterization
- Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve
Who cannot join
- Prior stroke or TIA within 3 months
- 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
- 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
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- 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 valve disease requiring surgery 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
- 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)
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site
Hospital of the Lithuanian University of Health Sciences ligoninė Kauno
Kaunas
About this study
Official title: Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
Read the detailed description
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
- Conditions
- Mitral Regurgitation
- Being tested
- Cardiovalve transfemoral Mitral valve system
- Keywords
- Mitral valve, Functional mitral regurgitation, Heart failure
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovalve transfemoral Mitral valve systemDevice
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovalve treatment | Experimental | Patients that implanted with the Cardiovalve device Receives: Device: Cardiovalve transfemoral Mitral valve system |
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
Freedom from major device or procedure related serious adverse events:
- Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h.
- Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Measured: 30 days
Secondary outcomes (1)
Technical success
Technical success; delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging Number of patients for whom the device was successfully implanted (per MVARC definitions) Number of patients with reduction in MR grade from Baseline Number of patients with improvement in NYHA class from baseline Number of patients with increase distance walked in the 6MW test from baseline.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start12 Oct 2017
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
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
- Model description
- Prospective, single-center, single-arm feasibility clinical study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovalve Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Rimantas Benetis, MD, Principal investigator, Head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958773
- Sponsor's protocol ID
- CP 17-01
- Status last verified
- Dec 2025
- First submitted
- 19 May 2019
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT03958773
- Acronym / sponsor ID
- CP 17-01
- Conditions
- Mitral Regurgitation
- Keywords
- Mitral valve, Functional mitral regurgitation, Heart failure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cardiovalve Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 22 May 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.
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
Detailed description
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, single-arm feasibility clinical study.
| Arm | Type | Receives |
|---|---|---|
| Cardiovalve treatment | Experimental | Device: Cardiovalve transfemoral Mitral valve systemPatients that implanted with the Cardiovalve device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- NYHA functional II, III or ambulatory IV
- Severe mitral regurgitation (MR grade 3-4+)
- High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum)
- Able to undergo Transesophageal Echocardiography (TEE).
Key exclusion criteria (28 listed)
- Prior stroke or TIA within 3 months
- 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
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 |
|---|---|---|
| Cardiovalve transfemoral Mitral valve systemCardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories. | Device | Cardiovalve treatment |
Primary outcome
Freedom from major device or procedure related serious adverse events
Time frame: 30 days
Freedom from major device or procedure related serious adverse events: F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h. I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
1 secondary outcome
Technical success
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- 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.
Rimantas Benetis, MD principal investigator
Head of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovalve transfemoral Mitral valve system in people with Mitral Regurgitation, run by Cardiovalve Ltd. at 1 site in Lithuania.
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 9 inclusion and 28 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: enrolling by invitation, as of the sponsor's last update on 5 Jan 2026. 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 Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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 5 Jan 2026.