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A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System (DISCOVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01845285
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Direct Flow Medical, Inc.

Brief Summary:

The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial indications. Procedures and assessments required by this registry are generally considered standard of care for Transcatheter Aortic Valve Replacement patients.

Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic imaging.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: Aortic Valve Replacement

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients With Severe Aortic Stenosis
Study Start Date : March 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
aortic valve disease
aortic valve replacement
Device: Aortic Valve Replacement
Transthoracic Echo (TTE),CT Scan (ECG triggered, contrast enhanced),Aorto-Iliac Angiogram,Peripheral Evaluation,Coronary Evaluation,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, Current Cardiac Medications, Transthoracic echo (TTE)
Other Names:
  • Direct Flow Medical Percutaneous Aortic Valve 18F System
  • Discover
  • Transcatheter

Primary Outcome Measures :
  1. Freedom from all-cause mortality at 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Device Success (VARC defined) [ Time Frame: 30 days ]
    • Absence of procedural mortality AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomic location AND
    • Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20mmHg or peak velocity <3m/s, AND no moderate or severe prosthetic valve regurgitation)

  2. Early Safety [ Time Frame: 30 days ]
    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute Kidney Injury - Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complications
    • Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)

  3. Clinical efficacy [ Time Frame: 30 days through 5 years ]
    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Hospitalization for valve-related symptoms or worsening congestive heart failure

  4. Clinical efficacy [ Time Frame: 30 days through 5 years ]
    • NYHA Class III or IV

  5. Clinical efficacy [ Time Frame: 30 days through 5 years ]
    • Prosthetic heart valve dysfunction (mean aortic valve gradient ≥20mm Hg, EOA ≤0.9-1.1cm2 [depending on body surface area] and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation)

  6. Time-related Valve Safety [ Time Frame: 5 years ]

    • Structural valve deterioration:

    • Valve-related dysfunction (mean aortic valve gradient (mean aortic valve gradient ≥20mmHg, EOA ≤0.9-1.1cm2 [depending on body surface area] and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation)
    • Requiring repeat procedure (TAVR or SAVR)

  7. Time-related Valve Safety [ Time Frame: 5 years ]
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thromboembolic events (e.g., stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g., trauma)

Information from the National Library of Medicine

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Ages Eligible for Study:   71 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Direct Flow Medical Transcatheter Aortic Valve System is intended for use in patients with severe aortic valve stenosis who require replacement of their native aortic valve but are extreme risk candidates for open surgical replacement. This is in accordance with the product Intended Use in the commercial Instructions for Use.

Candidates for this study must meet all of the Indications criteria and none of the Contraindications.

Inclusion Criteria (Indications):

  1. Age > 70 years old
  2. Severe aortic valve stenosis determined by echocardiogram and Doppler:

    • mean gradient >40 mmHg or peak jet velocity >4.0 m/s
    • aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
  3. Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope).
  4. 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.

Exclusion Criteria (Contraindications):

The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01845285

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Contact: Christopher Naber, MD +49201897 0
Contact: Mary Edwards 7075760420 ext 462

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Elisabeth Krankenhaus Recruiting
Essen, Germany, 45138
Contact: Christopher Naber, MD    +492018970   
Contact: Elisabeth Blank, RN    +49 201 8973218   
Principal Investigator: Christopher Naber, MD         
Ospedale Niguarda Ca' Granda Recruiting
Milan, Italy, 20162
Contact: Federico DeMarco, MD    +390264442585   
Principal Investigator: Federico DeMarco, MD         
Sponsors and Collaborators
Direct Flow Medical, Inc.
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Principal Investigator: Christopher Naber, MD Elisabeth Krankenhaus Essen GmbH

Additional Information:

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Responsible Party: Direct Flow Medical, Inc. Identifier: NCT01845285     History of Changes
Other Study ID Numbers: RP 001
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Direct Flow Medical, Inc.:
transcatheter valve replacement
aortic valve disease
aortic stenosis
Aortic regurgitation,catheter
Effective orifice area
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction