Clinical trial NCT02073864: A Study to Evaluate the Neuro-embolic Consequences of TAVR
Official title: Neurological Complications of Contemporary Unprotected TAVR (Yale Neuro TAVR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Aortic valve stenosis, stenosis, intervention
Lead sponsor: Keystone Heart
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for TAVR procedure

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of diffusion-weighted MRI lesions following TAVR without cerebral embolic protection
timeFrame: 1 week post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Fort Lee
country: United States
facility: Columbia University Medical Center
state: New Jersey
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Yale Cardiovascular Clinical Research
name: Alexandra Lansky, Md.
role: PRINCIPAL_INVESTIGATOR
References: