Cardiovalve Transfemoral System - FIM Study

Last updated: February 6, 2024
Sponsor: Cardiovalve Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Congestive Heart Failure

Treatment

Cardiovalve transfemoral Mitral valve system

Clinical Study ID

NCT03958773
CP 17-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theconsideration of the site Heart Team (including a cardiac surgeon, a cardiologist andimaging specialist as a minimum)
  • Able to undergo Transesophageal Echocardiography (TEE).
  • Subject understands the study requirements and the treatment procedures and provideswritten 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 thehospital.
  • Suitable for femoral access procedure and transseptal catheterization
  • Native mitral valve geometry and size and LV outflow tract characteristics compatiblewith the Cardiovalve

Exclusion

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 carotidsurgery within 30 days
  • Rheumatic heart disease or endocarditis within the previous 3 months
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, orany other structural heart disease causing heart failure other than dilatedcardiomyopathy of either ischemic or non-ischemic etiology
  • Existence of inferior vena cava filter or atrial septal device (contraindicatingfemoral 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 bypre-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 thisstudy
  • Hemodynamic instability defined as systolic pressure < 90mmHg or the need forinotropic support or intra-aortic balloon pump or other hemodynamic support device, orany 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 toantiplatelet, 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 oneyear
  • Active infection that requires antibiotic therapy
  • Subject is pregnant, breastfeeding or intend to become pregnant within one year

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Cardiovalve transfemoral Mitral valve system
Phase:
Study Start date:
October 12, 2017
Estimated Completion Date:
October 30, 2026

Study 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.

Connect with a study center

  • Hospital of the Lithuanian University of Health Sciences ligoninė Kauno

    Kaunas,
    Lithuania

    Active - Recruiting

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