A Study to Evaluate the Neuro-embolic Consequences of TAVR

NCT02073864 | Completed

• 1 other identifier: Yale Neuro TAVR
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Aortic Valve Stenosis

Keywords

Aortic valve stenosis, stenosis, intervention

Outcome Measures

Primary Outcomes (1)

• Incidence of diffusion-weighted MRI lesions following TAVR without cerebral embolic protection

  Number of new diffusion-weighted MRI lesions

  1 week post procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for TAVR procedure

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keystone Heart: lead

Study Sites (5)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Columbia University Medical Center

Fort Lee, New Jersey, 07024, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra Lansky, Md.

  Yale Cardiovascular Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2014
• First Posted: February 27, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

US (5)