Trans-aortic Valve Replacement and Renal Infarction

• Conditions: Renal Infarction

• Registration Number: NCT03474250
• Lead Sponsor: Sheba Medical Center

Brief Summary

Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement

Detailed Description

Each patient will undergo Magnetic Resonance assessment of the kidneys before the TAVR. on the third to 7th day after the ATVR, a second MRI to the kidneys will be performed. we will assess the changes and new lesions between both MRI tests and will perform a qualitative and quantitative measurement.

Study Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Status Verified: 2018-04
• Study Start: 2018-04-01
• Last Update Submitted: 2018-04-28
• Last Update Posted: 2018-05-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Severe symptomatic aortic stenosis
• Patient is able to lay down supine for 20 min (the time needed to perform the MRI) without any difficulties.

Exclusion Criteria

• Patient is on chronic renal replacement therapy (Dialysis)
• Documented Thrombus in the left ventricle or left atria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New Renal Infarction	one year	New low signal intensity lesions on diffusion weighted images on MRI.

Secondary Outcome Measures

Name	Time	Method
Hematuria	one year	New hematuria on urine test.
Elevation in Blood Pressure	one year	Delta of more than 5%
Elevation in Plasma Renin Activity	one year	Delta of more than 5%
Elevation in Aldosteron level	one year	Delta of more than 5%

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel