Mitral RegurgitationAHEADNCT03813524
Cardiovalve Transfemoral Mitral Valve System
A study testing Cardiovalve Transfemoral Mitral Valve in people with Mitral Regurgitation, run by Cardiovalve Ltd. at 2 sites in United States.
Trial summary
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Cardiovalve Transfemoral Mitral Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2019to 31 Mar 2020
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 85>Age ≥ 18 years
- Symptomatic (Stage D) severe MR confirmed by the echo core lab
- Cardiac Index > 2.0
- Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE)
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa
- Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure
- Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert).
Who cannot join
- MR etiology that is exclusively Primary (degenerative)
- Echocardiographic or angiographic evidence of severe mitral annular calcification
- Echocardiographic evidence of EROA < 0.3cm2
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology
- Hypotension (systolic pressure < 90 mm Hg)/Cardiogenic shock or other hemodynamic instability requiring the need for inotropic
Show all 32Show fewer
- Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure
- LVEDD >75 mm
- Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction.
- Anatomy deemed not suitable for the Cardiovalve
- Elevated Creatine Kinase-MB (CK-MB)
- UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
- Life Expectancy < 1 year due to non-cardiac conditions
- NYHA functional class IVb
- Chronic Kidney Disease with Creatinine clearance <30 ml/min/1.73m2
- Any prior mitral valve surgery or transcatheter mitral valve procedure
- Stroke or transient ischemic event within 30 Days prior to index procedure
- Modified Rankin Scale > 4 disability
- Class I indication for biventricular pacing (in patient with CRT device not implanted)
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure
- Need for cardiovascular surgery (other than MV disease)
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Active endocarditis
- Known severe symptomatic carotid stenosis (> 70 % via ultrasound)
- Active infections requiring current antibiotic therapy
- Active cancer with expected survival < one year
- Pregnant or planning pregnancy within next 12 months.
- Currently participating in an investigational drug or another device study
- Any condition making it unlikely the patient will be able to complete all procedures
- Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
- Subjects in whom transesophageal echocardiography is contraindicated
- Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, heparin, anticoagulation therapy) or hypersensitivity to nickel or titanium.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Columbia University Medical Center/NYPH
New York, New York, 10032
About this study
Official title: Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize 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 5 years.
Read the detailed description
The Cardiovalve offers a replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible.
Innovation: A truly transfemoral, trans venous delivery of the valve which minimizes procedural risk. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The experience to date is limited but thus far none of the clinical programs has been halted for safety reasons. Most of the technologies have focused on a transapical delivery approach (with mini-thoracotomy access) to further simplify the delivery method, with only a few allowing trans-septal delivery with femoral venous access.
- Conditions
- Mitral Regurgitation
- Being tested
- Cardiovalve Transfemoral Mitral Valve
- 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.
Cardiovalve Transfemoral Mitral ValveDevice
The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovalve Transfemoral Mitral Valve | Experimental | Replacement valve delivered through a transfemoral access and transseptal approach Receives: Device: Cardiovalve Transfemoral Mitral Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cardiovalve Technical Success
- Successful access, delivery and retrieval of the delivery system; and
- Successful deployment and correct positioning of the first intended implant; and
- Freedom from emergency surgery or reintervention related to the device or access procedure
Without any procedural mortality, stroke, and device dysfunction (Central MR grade > 1 or paravalvular leak moderate or severe, mean mitral gradient > 6 mm Hg, LVOT obstruction (gradient increase ≥10 mm Hg)) at 30-day follow up.
Measured: 30 Days
Number of Participants With Major Device Related Adverse Events Through 30 Days
- Death (Cardiovascular mortality vs non-cardiovascular);
- Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications;
- Disabling Stroke;
- Myocardial infarction (MVARC definition);
- Major access site and vascular complications
- Fatal or Life-threatening bleeding (MVARC Type III- V)
- Life-threatening arrhythmia;
- Renal Failure requiring dialysis;
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start26 Mar 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: COVID Impact; Sponsor decided to discontinue, no participants remaining, study closed 2024
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 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovalve Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiovascular Research Foundation, New York
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813524
- Sponsor's protocol ID
- CP 18-01
- Acronym
- AHEAD
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2019
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
- ClinicalTrials.gov ID
- NCT03813524
- Acronym / sponsor ID
- AHEAD / CP 18-01
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID Impact; Sponsor decided to discontinue, no participants remaining, study closed 2024
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cardiovalve Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cardiovascular Research Foundation, New York
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize 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 5 years.
Detailed description
The Cardiovalve offers a replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible.
Innovation: A truly transfemoral, trans venous delivery of the valve which minimizes procedural risk. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The experience to date is limited but thus far none of the clinical programs has been halted for safety reasons. Most of the technologies have focused on a transapical delivery approach (with mini-thoracotomy access) to further simplify the delivery method, with only a few allowing trans-septal delivery with femoral venous access.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovalve Transfemoral Mitral Valve | Experimental | Device: Cardiovalve Transfemoral Mitral ValveReplacement valve delivered through a transfemoral access and transseptal approach |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 85>Age ≥ 18 years
- Symptomatic (Stage D) severe MR confirmed by the echo core lab
- Cardiac Index > 2.0
- Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE)
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa
Key exclusion criteria (32 listed)
- MR etiology that is exclusively Primary (degenerative)
- Echocardiographic or angiographic evidence of severe mitral annular calcification
- Echocardiographic evidence of EROA < 0.3cm2
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology
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 ValveThe Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium. | Device | Cardiovalve Transfemoral Mitral Valve |
Primary outcome
Number of Participants With Cardiovalve Technical Success
Time frame: 30 Days
1. Successful access, delivery and retrieval of the delivery system; and 2. Successful deployment and correct positioning of the first intended implant; and 3. Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality, stroke, and device dysfunction (Central MR grade > 1 or paravalvular leak moderate or severe, mean mitral gradient > 6 mm Hg, LVOT obstruction (gradient increase ≥10 mm Hg)) at 30-day follow up.
Number of Participants With Major Device Related Adverse Events Through 30 Days
Time frame: 30 Days
1. Death (Cardiovascular mortality vs non-cardiovascular); 2. Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; 3. Disabling Stroke; 4. Myocardial infarction (MVARC definition); 5. Major access site and vascular complications 6. Fatal or Life-threatening bleeding (MVARC Type III- V) 7. Life-threatening arrhythmia; 8. Renal Failure requiring dialysis;
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 in people with Mitral Regurgitation, run by Cardiovalve Ltd. at 2 sites in United States.
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 7 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: stopped early, as of the sponsor's last update on 25 Jun 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 United States. 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 2 Jun 2026). 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?
Number of Participants With Cardiovalve Technical Success (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 25 Jun 2026.