Trans-aortic Valve Replacement and Renal Infarction

Renal Infarction Clinical Trial

Official title:

Trans-catheter Aortic Valve Replacement and Renal Infarction Among Patients With Severe Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03474250
• Other study ID #: 4887-18
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: Sheba Medical Center
• Contact: Arwa Younis, Doctor
• Phone: 0544731936
• Email: or.younis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Renal Infarction

Intervention

Diagnostic Test:
• Magnetic Resonance test for kidney
Magnetic Resonance test for kidney

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Renal Infarction	New low signal intensity lesions on diffusion weighted images on MRI.	one year
Secondary	Hematuria	New hematuria on urine test.	one year
Secondary	Elevation in Blood Pressure	Delta of more than 5%	one year
Secondary	Elevation in Plasma Renin Activity	Delta of more than 5%	one year
Secondary	Elevation in Aldosteron level	Delta of more than 5%	one year