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
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
Connect with a study center
Hospital of the Lithuanian University of Health Sciences ligoninė Kauno
Kaunas,
LithuaniaActive - Recruiting
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