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).

Not Applicable

• Conditions: Severe Symptomatic Aortic Stenosis
• Interventions: Device: MRI test

• Registration Number: NCT02210351
• Lead Sponsor: Sheba Medical Center

Brief Summary

The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Study First Posted: 2014-08-06
• Last Update Posted: 2014-08-06
• Study Start: 2014-09
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
2. Symptomatic patients with aortic stenosis referred for medically indicated AVR
3. Signed informed consent to participate in the study.

Exclusion Criteria

1. Inability to sign written informed consent.
2. Abnormal Apical dysfunction at baseline
3. LVEF < 20%
4. Pregnancy or breast feeding.
5. Need for emergency surgery for any reason.
6. Any case in which the practicing physician asserts that enrollment in the protocol will

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI test	MRI test	-

Primary Outcome Measures

Name	Time	Method
Change in left ventricle ejection fraction	two months after the surgery

Trial Locations

Locations (1)

Leviev Heart Center, Sheba Medical Center; 🇮🇱 Ramat Gan, Israel