Aortic Valve StenosisNCT01475799
Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
A study testing Replacement of the Aortic Stenotic Valve in people with Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 12 sites in 5 countries.
Trial summary
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Replacement of the Aortic Stenotic Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Nov 2011to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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)
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany5 sites
Vivantes Klinikum im Friedrichshain
Berlin, DE, 10623
University Hospital Bonn
Bonn
Elisabeth-Krankenhaus Essen, GmbH
Essen, 45138
Medical Care Center, Prof Mathey, Prof Schofer
Hamburg, 22527
Krankenhaus der Barmherzigen Brüder Trier
Trier
France2 sites
L'Institut Hospitalier Jacques Cartier
Massy, 91300
Clinique Pasteur
Toulouse, 31300
Italy2 sites
San Raffaele Hospital
Milan, 20132
Azienda Ospedaliera Niguarda Ca Granda
Milan
United Kingdom2 sites
St. Thomas' Hospital
London, London, SE1 7EH
St. Bartholomew's Hospital
London, EC1A 7BE
About this study
Official title: 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.
Read the 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
- Conditions
- Aortic Valve Stenosis
- Being tested
- Replacement of the Aortic Stenotic Valve
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replacement of the Aortic Stenotic ValveDevice
Also called TAVR
Treatment for patients with Severe Aortic Stenosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Replacement of the Aortic Stenotic Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from all-cause mortality from procedure to 30 days
Measured: Procedure to 30 days
Secondary outcomes (1)
Device Success at procedure completion
Device success is assessed at the completion of the study procedure based on TEE
Measured: At procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direct Flow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry LeFevre, M.D., Principal investigator, Study PIProf. Joachim Schofer, Principal investigator, Study PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475799
- Sponsor's protocol ID
- IP 010
- Status last verified
- Oct 2016
- First submitted
- 17 Nov 2011
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01475799
- Acronym / sponsor ID
- IP 010
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Direct Flow Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Aortic Valve 18F System | Experimental | Device: Replacement of the Aortic Stenotic ValveEvaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replacement of the Aortic Stenotic ValveAlso: TAVRTreatment for patients with Severe Aortic Stenosis. | Device | Percutaneous Aortic Valve 18F System |
Primary outcome
Freedom from all-cause mortality from procedure to 30 days
Time frame: Procedure to 30 days
1 secondary outcome
Device Success at procedure completion
Time frame: At procedure completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry LeFevre, M.D. principal investigator
Study PI
Prof. Joachim Schofer principal investigator
Study PI
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replacement of the Aortic Stenotic Valve in people with Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, France, Italy, United Kingdom, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from all-cause mortality from procedure to 30 days (time frame: Procedure to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.