A Study to Evaluate the Neuro-embolic Consequences of TAVR

Neurological Complications of Contemporary Unprotected TAVR (Yale Neuro TAVR)

A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis

Detailed Description

Prospective, multi-center study enrolling a minimum of 20 up to a maximum of 80 patients at up to six investigational sites in the United States and European Union. Patients meeting eligibility criteria for TAVR will be enrolled to undergo diffusion-weighted MRI brain imaging pre-procedure (optional) and post-procedure and neuropsychological testing pre- and post-procedure, and at 30 days of follow-up.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • New Jersey
    • Fort Lee, New Jersey, United States, 07024
      • Columbia University Medical Center
  • New York
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • Texas
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for TAVR procedure

Description

Inclusion Criteria:

• The patient must be ≥18 years of age.
• Patient meets indications for TAVR procedure.
• The patient is willing to comply with protocol-specified follow-up evaluations.
• The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:

• Patients undergoing TAVR via the trans-axillary, subclavian, or direct aortic route
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
• Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom creatine kinase and creatine kinase have not returned to within normal limits at the time of procedure.
• Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain.
• Patients with impaired renal function (estimated Glomerular Filtration Rate [Estimated Glomerular Filtration Rate] <30, calculated from serum creatinine by the Cockcroft-Gault formula).
• Patients with a platelet count of <100.000 cells/mm³ or > 700.000 cells/mm³ or a white blood cell< 3000 cells/mm³ within 7 days prior to index procedure or per standard local practice.
• 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 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.
• Patients with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, 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 peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months.
• Patients presenting with cardiogenic shock.
• Patients with documented friable or mobile atherosclerotic plaque in the aortic arch.
• Patients with contraindication to cerebral MRI.
• Patients with any other cardiovascular procedure prior to TAVR
• Patients with severe aortic arch atheroma visible on CT scan

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of diffusion-weighted MRI lesions following TAVR without cerebral embolic protection	Number of new diffusion-weighted MRI lesions	1 week post procedure

Collaborators and Investigators

• Sponsor: Keystone Heart
• Investigators: Principal Investigator: Alexandra Lansky, Md., Yale Cardiovascular Clinical Research

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: February 23, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (ESTIMATE): February 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Aortic valve stenosis, stenosis, intervention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: Yale Neuro TAVR