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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03813524
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : February 10, 2023
Sponsor:
Collaborators:
Cardiovalve Ltd.
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Boston Biomedical Associates

Study Description
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Brief 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. 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.

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

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : December 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cardiovalve Transfemoral Mitral Valve
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. 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.


  2. Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including: [ 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;


Secondary Outcome Measures :
  1. Mitral Regurgitation severity [ Time Frame: 30 days, 3 months, 6 months ]
  2. Change in LV end diastolic volume index (LVEDVI) [ Time Frame: 30 days, 3 months, 6 months ]
  3. Change in LV end systolic volume index (LVESVI) [ Time Frame: 30 days, 3 months, 6 months ]
  4. Changes in New York Heart Association (NYHA) functional class [ Time Frame: 30 days, 3 months, 6 months ]
    Class I-IV; Higher functional class represents more severe symptoms of heart failure

  5. 6-minute walk test (6MWT) distance [ Time Frame: 30 days, 3 months, 6 months ]
  6. Kansas City Cardiomyopathy Questionnaire (KCCQ) score [ Time Frame: 30 days, 3 months, 6 months ]

    3 subscales: Symptom Burden- range 0-100; Physical Limitation- range 0-100; Quality of Life- range 0-100;

    Higher score represents less burdensome symptoms within each subscale. The total KCCQ score represents the mean (average) of the three subscale scores.


  7. Clinical Frailty Score [ Time Frame: 30 days, 3 months, 6 months ]
    Scale from 1 to 9 Lower score indicates a lower level of frailty


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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.
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): NCT03813524


Locations
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United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
United States, New York
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Sponsors and Collaborators
Boston Biomedical Associates
Cardiovalve Ltd.
Cardiovascular Research Foundation, New York
More Information
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Responsible Party: Boston Biomedical Associates
ClinicalTrials.gov Identifier: NCT03813524    
Other Study ID Numbers: CP 18-01
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases