Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
NCT ID: NCT01475799
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
112 participants
INTERVENTIONAL
2011-11-30
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Percutaneous Aortic Valve 18F System
Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis.
Replacement of the Aortic Stenotic Valve
Treatment for patients with Severe Aortic Stenosis.
Interventions
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Replacement of the Aortic Stenotic Valve
Treatment for patients with Severe Aortic Stenosis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Symptomatic aortic valve stenosis demonstrated by angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope
3. 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
4. ≥ 70 years old
5. Patient has been informed of the nature of the study and has provided written informed consent
6. Patient and treating physician agree that the patient will return for all required post-procedure follow-up visits
Exclusion Criteria
1. Patient is a surgical candidate for aortic valve replacement
2. Congenital bicuspid or unicuspid valve determined by echocardiography
3. Native valve annulus diameter is \<17mm or \>22mm determined by the screening CT scan
4. Extreme asymmetrical calcification of the native aortic valve determined by the screening CT scan
5. Native valvular or peripheral vascular anatomy is not appropriate for the DFM bioprosthesis and 18F delivery system
6. Left ventricular ejection fraction (LVEF) \<30% determined by resting echocardiogram
7. Evidence of an acute myocardial infarction (Refer to Definitions in Section 8) within 30 days prior to the study procedure
8. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
9. Any planned surgical or percutaneous coronary or peripheral procedure to be performed during the study procedure or prior to 30 day follow-up visit
10. Need for emergency surgery for any reason
11. Untreated clinically significant ( \> 70% obstruction) coronary artery disease requiring revascularization
12. Prior aortic or mitral valve surgery
13. Pre-existing prosthetic heart valve in any position
14. Mitral insufficiency greater than moderate determined by resting echocardiography
15. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
16. Thoracic aortic aneurysm (TAA)
17. Abdominal aortic aneurysm (AAA) \>4.5 cm
18. Presence of an endovascular stent graft for treatment of AAA or TAA
19. Hypertrophic cardiomyopathy
20. Hemodynamic instability (e.g. requiring inotropic support)
21. Trans-esophageal echocardiography (TEE) is contraindicated
22. Renal insufficiency (creatinine \> 3.0 mg/dL) and/or end-stage renal disease requiring dialysis at the time of screening
23. Active endocarditis or sepsis within 6 months prior to the study procedure
24. Stroke or transient ischemic attack (TIA) within 6 months prior to the study procedure
25. Cardiogenic shock within 30 days prior to the study procedure
26. Active peptic ulcer or upper GI bleeding within 3 months prior to the study procedure
27. Leukopenia (WBC \<3000/mm³), acute anemia (Hb \<9 g/dL), or thrombocytopenia (platelet count \<100,000 cells/mm3)
28. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
29. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
30. Currently participating in an investigational drug or another device trial
31. Previously enrolled in this study
32. Patient refusal of surgery
33. Life expectancy thought to be \<12 months
34. Dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
70 Years
ALL
No
Sponsors
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Direct Flow Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thierry LeFevre, M.D.
Role: PRINCIPAL_INVESTIGATOR
Study PI
Prof. Joachim Schofer
Role: PRINCIPAL_INVESTIGATOR
Study PI
Locations
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L'Institut Hospitalier Jacques Cartier
Massy, , France
Clinique Pasteur
Toulouse, , France
Vivantes Klinikum im Friedrichshain
Berlin, DE, Germany
University Hospital Bonn
Bonn, , Germany
Elisabeth-Krankenhaus Essen, GmbH
Essen, , Germany
Medical Care Center, Prof Mathey, Prof Schofer
Hamburg, , Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, , Germany
San Raffaele Hospital
Milan, , Italy
Azienda Ospedaliera Niguarda Ca Granda
Milan, , Italy
Centre hospitalier de Luxembourg
Luxembourg, , Luxembourg
St. Thomas' Hospital
London, London, United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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IP 010
Identifier Type: -
Identifier Source: org_study_id