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).

Severe Symptomatic Aortic Stenosis Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02210351
• Other study ID #: SHEBA-13-0829-DS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 5, 2014
• Last updated: August 5, 2014
• Start date: September 2014

Study information

• Verified date: August 2014
• Source: Sheba Medical Center
• Contact: Danny Spiegelstein, Dr
• Phone: 972-35307339
• Email: Danny.Spiegelstein[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Healtn
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Symptomatic Aortic Stenosis

Intervention

Device:
• MRI test

Locations

Country	Name	City	State
Israel	Leviev Heart Center, Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricle ejection fraction		two months after the surgery	No