Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
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ClinicalTrials.gov Identifier: NCT01475799 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 21, 2011
Last Update Posted
: November 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aortic Valve Stenosis | Device: Replacement of the Aortic Stenotic Valve | Not Applicable |
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 |

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
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- Freedom from all-cause mortality from procedure to 30 days [ Time Frame: Procedure to 30 days ]
- Device Success at procedure completion [ Time Frame: At procedure completion ]Device success is assessed at the completion of the study procedure based on TEE

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475799
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 |
Principal Investigator: | Thierry LeFevre, M.D. | Study PI | |
Principal Investigator: | Prof. Joachim Schofer | Study PI |
Responsible Party: | Direct Flow Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT01475799 History of Changes |
Other Study ID Numbers: |
IP 010 |
First Posted: | November 21, 2011 Key Record Dates |
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 |