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Cardiovalve Transfemoral System - FIM Study

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ClinicalTrials.gov Identifier: NCT03958773
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Meditrial Europe Ltd.
Information provided by (Responsible Party):
Cardiovalve Ltd.

Brief 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-center, single-arm feasibility clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : September 12, 2020
Estimated Study Completion Date : September 12, 2021

Arm Intervention/treatment
Experimental: Cardiovalve treatment Device: Cardiovalve system
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Technical success [ Time Frame: Intraoperative ]
    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



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

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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

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): NCT03958773


Contacts
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Contact: Nitza Shoham, PhD +972765388142 ext 8142 nitza@cardiovalve.com
Contact: Ronit Pick ronit@cardiovalve.com

Locations
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Lithuania
Hospital of the Lithuanian University of Health Sciences ligoninė Kauno Recruiting
Kaunas, Lithuania
Contact: Rimantas Benetis, MD         
Sponsors and Collaborators
Cardiovalve Ltd.
Meditrial Europe Ltd.
Investigators
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Principal Investigator: Rimantas Benetis, MD Head of department

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Responsible Party: Cardiovalve Ltd.
ClinicalTrials.gov Identifier: NCT03958773     History of Changes
Other Study ID Numbers: CP 17-01
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
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

Keywords provided by Cardiovalve Ltd.:
Mitral valve
Functional mitral regurgitation
Heart failure

Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases