The Direct Flow Medical TranScatheter Aortic Valve RepLacement System US Feasibility Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Direct Flow Medical, Inc.
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Freedom from all cause mortality/Device success
- Last Updated
- 9 years ago
Overview
Brief Summary
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery.
Detailed Description
The Direct Flow Medical Transcatheter Aortic Valve System is indicated for symptomatic patients who require replacement of their native aortic valve and have a predicted operative mortality or serious morbidity risk of equal or greater 50% at 30 days with surgical aortic valve replacement or are deemed unsuitable for surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient has severe senile degenerative aortic valve stenosis determined by resting or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean gradient \>40 mmHg or peak jet velocity \>4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m
- •The patient has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥III).
- •The patient must have a predicted risk of operative mortality or serious irreversible morbidity of \>50% at 30 days, or be deemed not suitable for surgery for other reasons. This conclusion shall be based on consensus of one cardiologist and two cardiac surgeons at the investigational site after careful consideration of the patient's STS risk score and co-morbidities, and after at least one of the surgeons participating in the decision has personally examined the patient.
- •The patient been informed of the nature of the study, agrees to its provisions, is willing to comply with protocol-specified follow-up evaluations and has provided written informed consent, approved by the appropriate IRB.
- •Exclusion Criteria
- •Left ventricular ejection fraction (LVEF) \<20% determined by resting echocardiogram
- •Patients with an acute MI within 30 days preceding the index procedure.
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
- •Patients with impaired renal function (estimated Glomerular Filtration Rate \[eGFR\] \<20cc/min, calculated from serum creatinine by the Cockcroft-Gault formula)
- •Patients with a platelet count of \<50,000 cells/mm³ or a WBC \< 1000 cells/mm³ within 7 days prior to index procedure.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Freedom from all cause mortality/Device success
Time Frame: 6 months post procedure
Absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomic location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient less than 20 mmHg or peak velocity less than 3m/s, AND no moderate or severe prosthetic valve regurgitation.
Secondary Outcomes
- Time-related Valve Safety(30 days, 6 months and annually at 1 to 5 years)
- Clinical Endpoints(30 days, 6 months and annually at 1 to 5 years.)
- Early Safety(30 Days)
- Clinical Efficacy(6 months,and annually at 1 to 5 years)