NCT02210351

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

2.3 years

First QC Date

August 5, 2014

Last Update Submit

August 5, 2014

Conditions

Severe Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricle ejection fraction

    two months after the surgery

Study Arms (1)

MRI test

EXPERIMENTAL
Device: MRI test

Interventions

MRI testDEVICE
MRI test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leviev Heart Center, Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Central Study Contacts

Danny Spiegelstein, Dr

CONTACT

972-35307339Danny.Spiegelstein@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Danny Spiegelstein, Physician

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2017

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

IL(1)