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).

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02210351
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Symptomatic Aortic Stenosis	Device: MRI test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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).
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRI test	Device: MRI test

Outcome Measures

Primary Outcome Measures

1. Change in left ventricle ejection fraction [two months after the surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leviev Heart Center, Sheba Medical Center	Ramat Gan		Israel	5265601

Sponsors and Collaborators

• Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Danny Spiegelstein, Dr. Danny Spiegelstein, Physician, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT02210351
• Other Study ID Numbers: SHEBA-13-0829-DS-CTIL
• First Posted: Aug 6, 2014
• Last Update Posted: Aug 6, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Aug 6, 2014