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).

NCT ID: NCT02210351

Last Updated: 2014-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Severe Symptomatic Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI test

Group Type EXPERIMENTAL

MRI test

Intervention Type DEVICE

Interventions

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MRI test

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Danny Spiegelstein

Dr. Danny Spiegelstein, Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Leviev Heart Center, Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Danny Spiegelstein, Dr

Role: CONTACT

972-35307339

Facility Contacts

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Danny Spiegelstein, Dr

Role: primary

972-35307339

Other Identifiers

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SHEBA-13-0829-DS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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