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

NCT01475799 | Unknown DMC

• 1 other identifier: IP 010
• Study Type: interventional
• Target: 112
• Locations: 5 countries
• Sites: 12

Brief Summary

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Freedom from all-cause mortality from procedure to 30 days

  Procedure to 30 days

Secondary Outcomes (1)

• Device Success at procedure completion

  At procedure completion

Study Arms (1)

Percutaneous Aortic Valve 18F System

EXPERIMENTAL

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

Interventions

Replacement of the Aortic Stenotic Valve DEVICE

Treatment for patients with Severe Aortic Stenosis.

Also known as: TAVR

Percutaneous Aortic Valve 18F System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Symptomatic aortic valve stenosis demonstrated by 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
• ≥ 70 years old
• Patient has been informed of the nature of the study and has provided written informed consent
• Patient and treating physician agree that the patient will return for all required post-procedure follow-up visits

You may not qualify if:

• Candidates will be excluded from the study if any of the following criteria are present:
• Patient is a surgical candidate for aortic valve replacement
• Congenital bicuspid or unicuspid valve determined by echocardiography
• Native valve annulus diameter is \<17mm or \>22mm determined by the screening CT scan
• Extreme asymmetrical calcification of the native aortic valve determined by the screening CT scan
• Native valvular or peripheral vascular anatomy is not appropriate for the DFM bioprosthesis and 18F delivery system
• Left ventricular ejection fraction (LVEF) \<30% determined by resting echocardiogram
• Evidence of an acute myocardial infarction (Refer to Definitions in Section 8) within 30 days prior to the study procedure
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
• Any planned surgical or percutaneous coronary or peripheral procedure to be performed during the study procedure or prior to 30 day follow-up visit
• Need for emergency surgery for any reason
• Untreated clinically significant ( \> 70% obstruction) coronary artery disease requiring revascularization
• Prior aortic or mitral valve surgery
• Pre-existing prosthetic heart valve in any position
• Mitral insufficiency greater than moderate determined by resting echocardiography

Sponsors & Collaborators

• Direct Flow Medical, Inc.: lead

Study Sites (12)

L'Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Vivantes Klinikum im Friedrichshain

Berlin, DE, 10623, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

Elisabeth-Krankenhaus Essen, GmbH

Essen, 45138, Germany

Location

Medical Care Center, Prof Mathey, Prof Schofer

Hamburg, 22527, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Azienda Ospedaliera Niguarda Ca Granda

Milan, Italy

Location

Centre hospitalier de Luxembourg

Luxembourg, Luxembourg

Location

St. Thomas' Hospital

London, London, SE1 7EH, United Kingdom

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Thierry LeFevre, M.D.

  Study PI

  PRINCIPAL INVESTIGATOR

• Prof. Joachim Schofer

  Study PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2019
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

IT (2); LU (1); FR (2); GB (2); DE (5)