Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Study Description

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Brief Summary:

The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.

Condition or disease	Intervention/treatment	Phase
Aortic Valve Stenosis	Device: Replacement of the Aortic Stenotic Valve	Not Applicable

Detailed Description:

Prospective, multicenter, non-randomized clinical trial of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	112 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
Study Start Date :	November 2011
Actual Primary Completion Date :	July 2014
Estimated Study Completion Date :	July 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	Device: Replacement of the Aortic Stenotic Valve; Treatment for patients with Severe Aortic Stenosis.; Other Name: TAVR

Outcome Measures

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Primary Outcome Measures :

1. Freedom from all-cause mortality from procedure to 30 days [ Time Frame: Procedure to 30 days ]

Secondary Outcome Measures :

1. Device Success at procedure completion [ Time Frame: At procedure completion ]
   Device success is assessed at the completion of the study procedure based on TEE

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

All candidates for the study must meet the following inclusion criteria:

1. Severe aortic valve stenosis determined by echocardiogram and Doppler, 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/m2
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

Candidates will be excluded from the study if any of the following criteria are present:

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)

Contacts and Locations

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Locations

France
L'Institut Hospitalier Jacques Cartier
Massy, France, 91300
Clinique Pasteur
Toulouse, France, 31300
Germany
Vivantes Klinikum im Friedrichshain
Berlin, DE, Germany, 10623
University Hospital Bonn
Bonn, Germany
Elisabeth-Krankenhaus Essen, GmbH
Essen, Germany, 45138
Medical Care Center, Prof Mathey, Prof Schofer
Hamburg, Germany, 22527
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Italy
San Raffaele Hospital
Milan, Italy, 20132
Azienda Ospedaliera Niguarda Ca Granda
Milan, Italy
Luxembourg
Centre hospitalier de Luxembourg
Luxembourg, Luxembourg
United Kingdom
St. Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
St. Thomas' Hospital
London, United Kingdom, SE1 7EH

Sponsors and Collaborators

Direct Flow Medical, Inc.

Investigators

Principal Investigator:	Thierry LeFevre, M.D.	Study PI
Principal Investigator:	Prof. Joachim Schofer	Study PI

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Direct Flow Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01475799 History of Changes
Other Study ID Numbers:	IP 010
First Posted:	November 21, 2011
Last Update Posted:	November 1, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:

Constriction, Pathologic; Aortic Valve Stenosis; Pathological Conditions, Anatomical; Heart Valve Diseases	Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction