- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475799
Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
October 31, 2016 updated by: Direct Flow Medical, Inc.
Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massy, France, 91300
- L'Institut Hospitalier Jacques Cartier
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Toulouse, France, 31300
- Clinique Pasteur
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Bonn, Germany
- University Hospital Bonn
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Essen, Germany, 45138
- Elisabeth-Krankenhaus Essen, GmbH
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Hamburg, Germany, 22527
- Medical Care Center, Prof Mathey, Prof Schofer
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Trier, Germany
- Krankenhaus der Barmherzigen Brüder Trier
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DE
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Berlin, DE, Germany, 10623
- Vivantes Klinikum Im Friedrichshain
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Milan, Italy, 20132
- San Raffaele Hospital
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Milan, Italy
- Azienda Ospedaliera Niguarda Cà Granda
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Luxembourg, Luxembourg
- Centre Hospitalier de Luxembourg
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London, United Kingdom, SE1 7EH
- St. Thomas' Hospital
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London, United Kingdom, EC1A 7BE
- St. Bartholomew's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
All candidates for the study must meet the following inclusion criteria:
- 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
Exclusion Criteria
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
- Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- Thoracic aortic aneurysm (TAA)
- Abdominal aortic aneurysm (AAA) >4.5 cm
- Presence of an endovascular stent graft for treatment of AAA or TAA
- Hypertrophic cardiomyopathy
- Hemodynamic instability (e.g. requiring inotropic support)
- Trans-esophageal echocardiography (TEE) is contraindicated
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end-stage renal disease requiring dialysis at the time of screening
- Active endocarditis or sepsis within 6 months prior to the study procedure
- Stroke or transient ischemic attack (TIA) within 6 months prior to the study procedure
- Cardiogenic shock within 30 days prior to the study procedure
- Active peptic ulcer or upper GI bleeding within 3 months prior to the study procedure
- Leukopenia (WBC <3000/mm³), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <100,000 cells/mm3)
- History of bleeding diathesis or coagulopathy or refusal of blood transfusions
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
- Currently participating in an investigational drug or another device trial
- Previously enrolled in this study
- Patient refusal of surgery
- Life expectancy thought to be <12 months
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Treatment for patients with Severe Aortic Stenosis.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Freedom from all-cause mortality from procedure to 30 days
Time Frame: Procedure to 30 days
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Procedure to 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Device Success at procedure completion
Time Frame: At procedure completion
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Device success is assessed at the completion of the study procedure based on TEE
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At procedure completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thierry LeFevre, M.D., Study PI
- Principal Investigator: Prof. Joachim Schofer, Study PI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
November 17, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 21, 2011
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 31, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IP 010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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