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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Direct Flow Medical, Inc.
Information provided by (Responsible Party):
Direct Flow Medical, Inc. Identifier:
First received: April 30, 2013
Last updated: February 23, 2016
Last verified: February 2016

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 Intervention
Aortic Valve Stenosis
Device: Aortic Valve Replacement

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Direct Flow Medical, Inc.:

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

Secondary Outcome Measures:
  • 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)

  • 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)

  • 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

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

  • 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)

  • 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)

  • 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)

Estimated Enrollment: 1000
Study Start Date: March 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   71 Years and older   (Senior)
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01845285

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

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.
Principal Investigator: Christopher Naber, MD Elisabeth Krankenhaus Essen GmbH
  More Information

Responsible Party: Direct Flow Medical, Inc. Identifier: NCT01845285     History of Changes
Other Study ID Numbers: RP 001
Study First Received: April 30, 2013
Last Updated: February 23, 2016
Individual Participant Data  
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:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on May 24, 2017