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).

Sheba Medical Center

Status: Unknown

Conditions: Severe Symptomatic Aortic Stenosis

Treatments: Device: MRI test

Study type: Interventional

Funder types: Other

Identifiers

NCT02210351

SHEBA-13-0829-DS-CTIL

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

MRI test

Experimental group

Treatment:

Device: MRI test