Back to resultsEvaluation 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).
Primary Purpose
Severe Symptomatic Aortic Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MRI test
Sponsored by
About this trial
This is an interventional diagnostic trial for Severe Symptomatic Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Leviev Heart Center, Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI test
Arm Description
Outcomes
Primary Outcome Measures
Change in left ventricle ejection fraction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02210351
Brief 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).
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Symptomatic Aortic Stenosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI test
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI test
Primary Outcome Measure Information:
Title
Change in left ventricle ejection fraction
Time Frame
two months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danny Spiegelstein, Dr
Phone
972-35307339
Email
Danny.Spiegelstein@sheba.health.gov.il
Facility Information:
Facility Name
Leviev Heart Center, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Spiegelstein, Dr
Phone
972-35307339
Email
Danny.Spiegelstein@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
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).
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