Status:
UNKNOWN
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
Lead Sponsor:
Sheba Medical Center
Conditions:
Severe Symptomatic Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.
Eligibility Criteria
Inclusion
- Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
- Symptomatic patients with aortic stenosis referred for medically indicated AVR
- Signed informed consent to participate in the study.
Exclusion
- Inability to sign written informed consent.
- Abnormal Apical dysfunction at baseline
- LVEF \< 20%
- Pregnancy or breast feeding.
- Need for emergency surgery for any reason.
- Any case in which the practicing physician asserts that enrollment in the protocol will
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02210351
Start Date
September 1 2014
Last Update
August 6 2014
Active Locations (1)
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1
Leviev Heart Center, Sheba Medical Center
Ramat Gan, Israel, 5265601