Cardiovalve Transfemoral Mitral Valve System

NCT03813524 | Terminated DMC FDA Device

• 1 other identifier: CP 18-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• Cardiovalve Technical Success

  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.

  30 Days

• Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:

  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;

  30 Days

Secondary Outcomes (7)

• Mitral Regurgitation severity

  30 days, 3 months, 6 months

• Change in LV end diastolic volume index (LVEDVI)

  30 days, 3 months, 6 months

• Change in LV end systolic volume index (LVESVI)

  30 days, 3 months, 6 months

• Changes in New York Heart Association (NYHA) functional class

  30 days, 3 months, 6 months

• 6-minute walk test (6MWT) distance

  30 days, 3 months, 6 months

Study Arms (1)

Cardiovalve Transfemoral Mitral Valve

EXPERIMENTAL

Replacement valve delivered through a transfemoral access and transseptal approach

Device: Cardiovalve Transfemoral Mitral Valve

Interventions

Cardiovalve Transfemoral Mitral Valve DEVICE

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.

Cardiovalve Transfemoral Mitral Valve

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Biomedical Associates: lead
• Cardiovalve Ltd.: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (2)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 23, 2019
• Study Start: March 26, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)