Status:
UNKNOWN
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
Lead Sponsor:
Direct Flow Medical, Inc.
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
71+ years
Brief Summary
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the a...
Detailed Description
The patient population will include patients who are candidates for transcatheter aortic valve replacement (TAVR). According to routine practice, the heart team (interventional cardiologist and cardio...
Eligibility Criteria
Inclusion
- Candidates for this study must meet all of the Indications criteria and none of the Contraindications.
- Inclusion Criteria (Indications):
- Age \> 70 years old
- Severe aortic valve stenosis determined by echocardiogram and Doppler:
- mean gradient \>40 mmHg or peak jet velocity \>4.0 m/s
- aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
- Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope).
- Patient is an extreme risk candidate for open surgical aortic valve repair such that the site Investigators (interventional cardiologist and cardiothoracic surgeon) agree that medical factors preclude operation, based on the conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement due to the patient's co-morbidities (such as, but not limited to, severe COPD, porcelain aorta, previous thorax irradiation) or logistic EuroSCORE ≥ 20.
- Exclusion Criteria (Contraindications):
- The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01845285
Start Date
March 1 2013
End Date
December 1 2019
Last Update
February 24 2016
Active Locations (2)
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1
Elisabeth Krankenhaus
Essen, Germany, 45138
2
Ospedale Niguarda Ca' Granda
Milan, Italy, 20162