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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339115
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : July 29, 2022
Sponsor:
Collaborators:
Meditrial Europe Ltd.
Meditrial SrL
Information provided by (Responsible Party):
Cardiovalve Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Valve Disease Device: Cardiovalve Transfemoral Mitral Valve Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: European Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System (AHEAD Study)
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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]


  2. 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


  3. 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

  4. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339115


Contacts
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Contact: Nitza Shoham, VP CA&A +972765388142 nitza@cardiovalve.com
Contact: Lauren Beker, PhD lbaker@boston-biomedical.com

Locations
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Germany
Universitätsklinikum Bonn Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53127
Contact: Georg Nickenig, MD    +4922828715217    georg.nickenig@ukbonn.de   
Principal Investigator: Georg Nickenig, MD         
Sub-Investigator: Nikos Werner, MD         
Sub-Investigator: Jan-Malte Sinning, MD         
Sub-Investigator: Marcel Weber, MD         
Herzzentrum der Uniklinik Köln Not yet recruiting
Köln, Germany
Contact: Stephan Baldus, MD    +49 221 478 32511    stephan.baldus@uk-koeln.de   
Principal Investigator: Stephan Baldus, MD         
Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck Recruiting
Lübeck, Germany
Contact: Christian Frerker    0451 500-44501    christian.frerker@uksh.de   
Universitaet_Mainz Not yet recruiting
Mainz, Germany
Contact: Stephan von Bardeleben, MD         
Contact: Tobias Ruf, MD       Tobias.Ruf@unimedizin-mainz.de   
Klinikum der Universität München LMU Recruiting
München, Germany
Contact: Jörg Hausleiter, MD    +49 89 4400 72361    joerg.hausleiter@med.uni-münchen.de   
Principal Investigator: Jörg Hausleiter, MD         
Greece
Hygea Recruiting
Athens, Greece
Contact: Konstantinos Spargias       kspargias@yahoo.com   
Italy
Maria Cecilia Hospital Recruiting
Cotignola, Italy
Contact: Antonio Colombo, MD         
Fondazione Toscana G. Monasterio-Ospedale del Cuore Recruiting
Massa, Italy, 54100
Contact: Sergio Berti, Dr.         
San Raffaele Hospital Recruiting
Milano, Italy, 20129
Contact: Paolo Denti, Dr.       denti.paolo@hsr.it   
Policlinico San Donato Recruiting
Milano, Italy
Contact: Francesco Bedogni, MD    +39 02 5277 4570    francesco.bedogni@grupposandonato.it   
A.O.U. Pisana Recruiting
Pisa, Italy, 56126
Contact: Anna S Petronio, Dr.         
Sponsors and Collaborators
Cardiovalve Ltd.
Meditrial Europe Ltd.
Meditrial SrL
Investigators
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Study Director: Nitza Shoham, VP CA&RA Cardiovalve Ltd.
More Information
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Responsible Party: Cardiovalve Ltd.
ClinicalTrials.gov Identifier: NCT03339115    
Other Study ID Numbers: CP 17-02
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Cardiovalve Ltd.:
Mitral Insufficiency
Heart Failure
Mitral Valve
Heart Diseases
Valvular Heart Disease
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases