Transcatheter Aortic Valve Replacement System Pivotal Trial

NCT02163850 | Unknown DMC

• 1 other identifier: IP 011, G120160
• Study Type: interventional
• Target: 878
• Locations: 1 country
• Sites: 3

Brief Summary

Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Death (all cause) and disabling stroke.

  The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year.

  12 Months

Study Arms (2)

Direct Flow Medical

EXPERIMENTAL

Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)

Device: Direct Flow Medical

Commercially Available

ACTIVE COMPARATOR

Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)

Device: Commercially Available

Interventions

Direct Flow Medical DEVICE

Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)

Also known as: TAVR

Direct Flow Medical

Commercially Available DEVICE

Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)

Also known as: TAVR

Commercially Available

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has severe senile degenerative aortic valve stenosis determined by echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg, or an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.
• The subject has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥II).
• Subject has a documented aortic annulus size of ≥22 mm and \<29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient Review Committee \[PRC\]) and is deemed treatable with an available size of both test and control device.
• There is agreement by the heart team (which must include a site cardiac interventionalist and two cardiac surgeons which can be either two cardiac surgeon staff members at the hospital where the procedure is to be performed or one surgeon from the hospital where the procedure is to be performed and a surgeon from the referring institution or practice) that subject is at high operative risk or greater of serious morbidity or mortality with surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and PRC confirmation) and that TAVR is appropriate. Subjects will be designated either extreme risk (defined as a mortality or irreversible morbidity 50% or great at 30 days) or high risk (i.e., Society of Thoracic Surgeons operative risk score \>8% or at a \> 15% risk of surgical mortality at 30 days but not extreme risk). This conclusion shall be based on consensus of one cardiac interventionalist and two cardiac surgeons that have reviewed the case after careful consideration of the Subject's STS risk score and co-morbidities.
• Subject understands the study requirements and the treatment procedures, and provides written informed consent.
• Subject agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

You may not qualify if:

• Left ventricular ejection fraction (LVEF) \<20% determined by resting echocardiogram.
• Subjects with an acute STEMI within 30 days preceding the index procedure.
• Chronic kidney disease with creatinine clearance \< 20 ml/min.
• Subjects with a platelet count of \<50,000 cells/mm³ or a WBC \< 1000 cells/mm³ within 7 days prior to index procedure.
• Subject has a known contraindication or hypersensitivity to all antithrombin regimens (aspirin, all P2Y12 inhibitors) that cannot be adequately pretreated, or inability to be anti-coagulated for the study procedure. Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel.
• Any subject with a balloon valvuloplasty (BAV) within 72 hours prior to the index procedure.
• Subjects who are on a waiting list for any organ transplant.
• Subjects with known other medical illness associated with a life expectancy of less than one year, or expectation that subject will not improve despite treatment of aortic stenosis.
• Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, or polyurethanes.
• Subjects with a history of a stroke or transient ischemic attack (TIA) within previous 60 days of index procedure.
• Subjects with an active gastrointestinal (GI) bleed or bleeding precluding dual antiplatelet therapy.
• Subjects presenting with hemodynamic instability or cardiogenic shock requiring inotropic support or mechanical support devices.
• Subjects who have a planned treatment with any other investigational device or procedure through 1 year follow-up, or who are currently participating in an investigational drug or another device trial.
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TAVR procedure.
• Untreated clinically significant coronary artery disease requiring revascularization.

Sponsors & Collaborators

• Direct Flow Medical, Inc.: lead

Study Sites (3)

NewYork-Presbyterian / Columbia Univ.

New York, New York, 10032, United States

RECRUITING

Ohio Health Riverside Methodist

Columbus, Ohio, 43214, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Scott Lim, M.D.

  Associate Professor of Pediatrics and Medicine and Director of Advanced Cardiac Valve Center at University of Virginia

  PRINCIPAL INVESTIGATOR

• Isacc George

  Columbia University, Assitant Professor of Surgery Division of Cadiothoracic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Edwards

CONTACT

707-576-0420; medwards@directflowmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2021
• Last Updated: May 3, 2016

Record last verified: 2016-04

Locations

US (3)