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

Aortic Valve Stenosis Clinical Trial

Official title:

Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01475799
• Other study ID #: IP 010
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2011
• Last updated: October 31, 2016
• Start date: November 2011
• Est. completion date: July 2019

Study information

• Verified date: October 2016
• Source: Direct Flow Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: July 2019
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Replacement of the Aortic Stenotic Valve
Treatment for patients with Severe Aortic Stenosis.

Locations

Country	Name	City	State
France	L'Institut Hospitalier Jacques Cartier	Massy
France	Clinique Pasteur	Toulouse
Germany	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
Italy	Azienda Ospedaliera Niguarda Ca Granda	Milan
Italy	San Raffaele Hospital	Milan
Luxembourg	Centre hospitalier de Luxembourg	Luxembourg
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Direct Flow Medical, Inc.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Luxembourg,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from all-cause mortality from procedure to 30 days		Procedure to 30 days	Yes
Secondary	Device Success at procedure completion	Device success is assessed at the completion of the study procedure based on TEE	At procedure completion	No