TranScatheter Aortic Valve RepLacement System US Feasibility Trial

NCT01932099 | Unknown Phase 2

• 2 other identifiers: IP 011G120160
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery.

Conditions

Aortic Valve Stenosis

Keywords

pathological constriction; restricted outflow, stenosis

Outcome Measures

Primary Outcomes (1)

• Freedom from all cause mortality/Device success

  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 less than 20 mmHg or peak velocity less than 3m/s, AND no moderate or severe prosthetic valve regurgitation.

  6 months post procedure

Secondary Outcomes (4)

• Early Safety

  30 Days

• Clinical Efficacy

  6 months,and annually at 1 to 5 years

• Time-related Valve Safety

  30 days, 6 months and annually at 1 to 5 years

• Clinical Endpoints

  30 days, 6 months and annually at 1 to 5 years.

Study Arms (1)

Single arm feasibility study

EXPERIMENTAL

Prospective, multi-center, single arm feasibility study. Subjects will include patients with severe aortic valve stenosis who require replacement of their native aortic valve. The intervention is transcatheter aortic valve replacement.

Device: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacement DEVICE

Direct Flow Medical Transcatheter Aortic Valve System is indicated for use in aortic stenosis for patients at extreme surgical risk for aortic valve replacement.

Also known as: Direct Flow Medical aortic valve system, TAVR

Single arm feasibility study

Eligibility Criteria

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

You may qualify if:

• The patient has severe senile degenerative aortic valve stenosis determined by resting or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization 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.
• The patient has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥III).
• The patient must have a predicted risk of operative mortality or serious irreversible morbidity of \>50% at 30 days, or be deemed not suitable for surgery for other reasons. This conclusion shall be based on consensus of one cardiologist and two cardiac surgeons at the investigational site after careful consideration of the patient's STS risk score and co-morbidities, and after at least one of the surgeons participating in the decision has personally examined the patient.
• The patient been informed of the nature of the study, agrees to its provisions, is willing to comply with protocol-specified follow-up evaluations and has provided written informed consent, approved by the appropriate IRB.

You may not qualify if:

• Left ventricular ejection fraction (LVEF) \<20% determined by resting echocardiogram
• Patients with an acute MI within 30 days preceding the index procedure.
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
• Patients with impaired renal function (estimated Glomerular Filtration Rate \[eGFR\] \<20cc/min, calculated from serum creatinine by the Cockcroft-Gault formula)
• Patients with a platelet count of \<50,000 cells/mm³ or a WBC \< 1000 cells/mm³ within 7 days prior to index procedure.
• Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion.
• Patients who have received any organ transplant or are on a waiting list for any organ transplant.
• Patients with known other medical illness (e.g. carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease) or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year, or expectation that patient will not improve despite treatment of aortic stenosis.
• Patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, and/or contrast sensitivity that cannot be adequately pre-medicated.
• Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
• Patients with an active gastrointestinal (GI) bleeding within the prior 6 months.
• Patients presenting with hemodynamic instability or cardiogenic shock defined by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Patients who have a planned treatment with any other investigational device or procedure during the study period, or who are currently participating in an investigational drug or another device trial
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed prior to 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 (6)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University Hospital

St Louis, Missouri, 63110, United States

Location

Columbia Univ. Medical Center

New York, New York, 10032, United States

Location

Cleveland CLinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Constriction, Pathologic

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• E. Murat Tuzcu, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Patrick M McCarthy, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 30, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2018
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

US (6)