- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813524
Cardiovalve Transfemoral Mitral Valve System (AHEAD)
Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meaghan Dunn
- Phone Number: 508-691-7028
- Email: mdunn@Boston-biomedical.com
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Heart Institute
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center/NYPH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cardiovalve Transfemoral Mitral Valve
Replacement valve delivered through a transfemoral access and transseptal approach
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovalve Technical Success
Time Frame: 30 Days
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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
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Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:
Time Frame: 30 Days
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|
30 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mitral Regurgitation severity
Time Frame: 30 days, 3 months, 6 months
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30 days, 3 months, 6 months
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Change in LV end diastolic volume index (LVEDVI)
Time Frame: 30 days, 3 months, 6 months
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30 days, 3 months, 6 months
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Change in LV end systolic volume index (LVESVI)
Time Frame: 30 days, 3 months, 6 months
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30 days, 3 months, 6 months
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Changes in New York Heart Association (NYHA) functional class
Time Frame: 30 days, 3 months, 6 months
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Class I-IV; Higher functional class represents more severe symptoms of heart failure
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30 days, 3 months, 6 months
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6-minute walk test (6MWT) distance
Time Frame: 30 days, 3 months, 6 months
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30 days, 3 months, 6 months
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Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time Frame: 30 days, 3 months, 6 months
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3 subscales: Symptom Burden- range 0-100; Physical Limitation- range 0-100; Quality of Life- range 0-100; Higher score represents less burdensome symptoms within each subscale. The total KCCQ score represents the mean (average) of the three subscale scores. |
30 days, 3 months, 6 months
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Clinical Frailty Score
Time Frame: 30 days, 3 months, 6 months
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Scale from 1 to 9 Lower score indicates a lower level of frailty
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30 days, 3 months, 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP 18-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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