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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Direct Flow Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01845285
First received: April 30, 2013
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]
    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 <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation*)


Secondary Outcome Measures:
  • All cause mortality and VARC (Valvular Academic Research Consortium) defined safety and Effectiveness [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    • 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)


Other Outcome Measures:
  • All Cause Mortality and VARC (Valvular Academic Research Consortium) defined safety and Effectiveness [ Time Frame: after 30 days ] [ Designated as safety issue: Yes ]
    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Hospitalization for valve-related symptoms or worsening congestive heart failure†
    • NYHA Class III or IV Prosthetic heart valve dysfunction (mean aortic valve gradient ≥20 mm Hg, EOA ≤0.9-1.1 cm2‡ and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation*)


Estimated Enrollment: 250
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (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, Chest X-Ray,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, EQ-5D, Current Cardiac Medications, Transthoracic echo (TTE)
Other Names:
  • Direct Flow Medical Percutaneous Aortic Valve 18F System
  • Discover
  • Transcatheter

  Hide Detailed Description

Detailed Description:

The patient population will include patients who are candidates for transcatheter aortic valve replacement (TAVR). According to routine practice, the heart team (interventional cardiologist and cardiothoracic surgeon) makes a choice to use the Direct Flow Medical Aortic Valve System, compared to other available TAVR prostheses, on the basis of clinical and surgical considerations. Therefore, the valve is implanted when the heart team decides that this product is best suited to the specific patient.

In order to be enrolled in this Registry, the patient must be a candidate for the implantation of the Direct Flow Medical Transcatheter Aortic Valve System, based on the commercial indications as stated in the Instructions for Use.

Therefore, candidates for this study must meet the following criteria (Indications for Use):

  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 All the Registry clinical evaluations and tests performed are generally considered standard of care for TAVR patients. When these recommendations conflict with the standard of care at the Registry site, the standard of care should prevail. In addition to the standard of care, the Sponsor recommends one brief additional evaluation (the EQ-5D quality of life measure) be conducted. Failure to perform this evaluation shall not be considered a protocol deviation.

Baseline Clinical Evaluation

  • Medical History and Physical Exam
  • 12 lead ECG and Arrhythmia Assessment
  • Logistic EuroSCORE/STS Score
  • New York Heart Association (NYHA) functional status
  • Modified Rankin Score Assessment (mRS)
  • EQ-5D Quality of Life measure
  • Current Cardiac Medications Baseline Imaging Studies
  • Transthoracic Echo (TTE)
  • CT Scan (ECG triggered, contrast enhanced)
  • Aorto-Iliac Angiogram:

    1. Peripheral Evaluation
    2. Coronary Evaluation
  • Chest X-Ray

All patients will have clinical follow-up at hospital discharge, 30 days, 12 months and annually to 3 years and undergo the following evaluations:

  • Physical Exam
  • 12 lead ECG and Arrhythmia Assessment
  • New York Heart Association (NYHA) functional status
  • Modified Rankin Score Assessment (mRS) if symptomatic for stroke
  • EQ-5D Quality of Life measure
  • Current Cardiac Medications
  • Transthoracic echo (TTE) Patients in whom the heart team has planned to use the Direct Flow Medical Transcatheter Aortic Valve System valve, are informed of the DISCOVER Registry and their consent to participate is required. This study intends to monitor the clinical condition of the patient for a period of 3 years after the operation. By agreeing to participate, the patient agrees to undergo clinical assessments and specific tests at certain intervals (prior to the procedure; during the implantation; at hospital discharge, at 30 days after the procedure, and at 1 year, 2 and 3 years later); the patient also agrees to the collection of these daThe purpose of this Registry is to monitor outcomes data for the Direct Flow Medical Transcatheter Aortic Valve System in the Post Market phase. The primary outcome of interest is freedom from all-cause mortality at 30 days. The results from the pivotal CE mark study (IP 010) yielded a 30 day freedom from all-cause mortality rate of 97%. Should the "true" rate be 97%, then N=250 patients would provide an estimate of the rate with a margin of error of 2%, with 95% confidence.
  Eligibility

Ages Eligible for Study:   70 Years to 95 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

Age > 70 years old

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
  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 ClinicalTrials.gov identifier: NCT01845285

Locations
Germany
Elisabeth Krankenhaus
Essen, Germany, 45138
Italy
Ospedale Niguarda Ca' Granda
Milan, Italy, 20162
Sponsors and Collaborators
Direct Flow Medical, Inc.
Investigators
Principal Investigator: Christopher Naber, MD Elisabeth Krankenhaus Essen GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Direct Flow Medical, Inc.
ClinicalTrials.gov Identifier: NCT01845285     History of Changes
Other Study ID Numbers: RP 001
Study First Received: April 30, 2013
Last Updated: May 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Aortic Valve Stenosis
Constriction, Pathologic
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on November 20, 2014