AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System (AHEAD)

March 16, 2026 updated by: Cardiovalve Ltd.

European Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System (AHEAD Study)

This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System 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, and long-term clinical outcomes over a follow-up of 2 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Cardiovalve offers a mitral 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 trans femoral, trans venous delivery of the prosthetic mitral valve which minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust radial strength with decoupling of the atrial flange and ventricular portion which contains 24 grasping legs designed for atraumatic anchoring of the device to the native mitral annulus. Valve leaflets are made of bovine pericardium. 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 Cardiovalve delivery system (DS) is designed for transfemoral delivery of the Implant with transseptal access to the left atrium. The catheter assembly is used to center the implant relative to the native mitral valve plane and align it with the left ventricual apex-to-base axis. After valve implantation, the delivery system is withdrawn.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Cologne, Germany
        • Herzzentrum der Uniklinik Köln
      • Lübeck, Germany
        • Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck
      • Mainz, Germany
        • Universitaet_Mainz
      • München, Germany
        • Klinikum der Universität München LMU
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitatsklinikum Bonn
  • Greece
      • Athens, Greece
        • Hygea
  • Italy
      • Cotignola, Italy
        • Maria Cecilia Hospital
      • Massa, Italy, 54100
        • Fondazione Toscana G. Monasterio-Ospedale del Cuore
      • Milan, Italy
        • Policlinico San Donato
      • Milan, Italy, 20129
        • San Raffaele Hospital
      • Pisa, Italy, 56126
        • A.O.U. Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

General Inclusion Criteria

  1. Age ≥ 18 years
  2. NYHA functional II, III or ambulatory IV
  3. Severe mitral regurgitation (MR grade 3-4+)
  4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
  5. Elevated 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) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
  6. Able to undergo Transesophageal Echocardiography (TEE).
  7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

  8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital.

    Anatomical Inclusion Criteria

  9. Suitable for femoral access procedure and trans septal catheterization
  10. Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)

Cardiovascular Exclusion Criteria

  1. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
  2. Acute myocardial infarction within the previous 30 days
  3. Any prior heart valve surgery or transcatheter mitral intervention
  4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  5. Rheumatic heart disease or endocarditis within the previous 3 months
  6. 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
  7. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
  8. Untreated clinically significant coronary artery disease requiring revascularization
  9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
  10. Aortic or pulmonic valve disease requiring surgery

  11. CRT/ICD implant within 30 days

    Anatomical Exclusion Criteria (assessed by pre-procedural imaging)

  12. Left Ventricular Ejection Fraction (LVEF) <30%
  13. LV end diastolic diameter > 70mm
  14. Significant abnormalities of the mitral valve and sub-valvular apparatus.
  15. Severe mitral annular or leaflets calcification
  16. Left atrial or LV thrombus or vegetation
  17. Severe right ventricular dysfunction

  18. Severe tricuspid or aortic valve disease

    General Exclusion Criteria

  19. Subject who is currently participating in an investigational study, other than this study
  20. 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
  21. 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
  22. Bleeding diathesis or hypercoagulable state
  23. Active peptic ulcer or active gastrointestinal bleeding
  24. Pulmonary artery systolic pressure >70 mmHg
  25. Patients with renal insufficiency (creatinine > 2.5 mg/dL)
  26. Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months
  27. Subject with hepatic insufficiency
  28. Subject has a co-morbid illness that may result in a life expectancy of less than one year
  29. Active infection that requires antibiotic therapy
  30. Subject is pregnant, breastfeeding or intend to become pregnant within one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cardiovalve Transfemoral Mitral Valve
Mitral replacement valve delivered through a transfemoral access and transseptal approach
Device: Cardiovalve Transfemoral Mitral Valve
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary safety endpoint is freedom from all-cause mortality and major adverse events
Time Frame: 30 days, 3 Months, 6 Months, 12 Months, and 24 Months
Freedom from all-cause mortality, all cause hospitalization, major adverse cardiac events (MACE), major device- or procedure- related serious adverse events
30 days, 3 Months, 6 Months, 12 Months, and 24 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Intraoperative, 30 Days

Technical success:

I. Absence of procedural mortality

II. 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 [Time Frame:Intraoperative]

III. Freedom from emergency surgery or reintervention related to the device or access procedure [Time Frame: 30 days]
Intraoperative, 30 Days
Device Success
Time Frame: Intraoperative

I. Absence of procedural mortality or stroke

II. Proper placement and positioning of the device

III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure
Intraoperative
Device Success
Time Frame: 30 days, 3 Months, 6 Months, 12 Months, and 24 Months

IV. Continued intended safety and performance of the device including:

  1. No evidence of structural or functional failure
  2. No specific device-related technical failure issues and complications
  3. 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
30 days, 3 Months, 6 Months, 12 Months, and 24 Months
Patient Success
Time Frame: 30 days, 3 Months, 6 Months, 12 Months, and 24 Months

I. Device success (either optimal or acceptable) II. Patient returned to the pre-procedural setting

  • III. Freedom from rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, worsening of heart failure)
  • IV. Improvement from baseline in NYHA functional class Number of patients with improvement in NYHA class
  • V. Six minute walk test Increase in distance (m) from baseline
  • VI. Improvement from baseline in quality-of-life (Kansas City Cardiomyopathy Questionnaire improvement by ≥ 10)
30 days, 3 Months, 6 Months, 12 Months, and 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardiovalve Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Meditrial Europe Ltd.
Meditrial SrL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Georg Nickenig, Bonn Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP 17-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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