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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).

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).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02210351
Enrollment
45
Registered
2014-08-06
Start date
2014-09-30
Completion date
Unknown
Last updated
2014-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Symptomatic Aortic Stenosis

Brief summary

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

Interventions

DEVICEMRI test

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Change in left ventricle ejection fractiontwo months after the surgery

Countries

Israel

Contacts

Primary ContactDanny Spiegelstein, Dr
Danny.Spiegelstein@sheba.health.gov.il972-35307339

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026