Clinical trial NCT03813524: Cardiovalve Transfemoral Mitral Valve System
Official title: Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Boston Biomedical Associates
Sponsor class: OTHER
Collaborators: name: Cardiovalve Ltd.
name: Cardiovascular Research Foundation, New York
First posted: 2019-01-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cardiovalve Technical Success
timeFrame: 30 Days
measure: Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:
timeFrame: 30 Days
Secondary outcomes:
measure: Mitral Regurgitation severity
timeFrame: 30 days, 3 months, 6 months
measure: Change in LV end diastolic volume index (LVEDVI)
timeFrame: 30 days, 3 months, 6 months
measure: Change in LV end systolic volume index (LVESVI)
timeFrame: 30 days, 3 months, 6 months
measure: Changes in New York Heart Association (NYHA) functional class
timeFrame: 30 days, 3 months, 6 months
measure: 6-minute walk test (6MWT) distance
timeFrame: 30 days, 3 months, 6 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: 30 days, 3 months, 6 months
measure: Clinical Frailty Score
timeFrame: 30 days, 3 months, 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
Study officials:
References: