Trans-aortic Valve Replacement and Renal Infarction

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

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

Study Overview

• Status: Unknown
• Conditions: Renal Infarction
• Intervention / Treatment: Diagnostic test: Magnetic Resonance test for kidney

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Arwa Younis, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients that will be undergoing trans-cather aortic valve replacement for severe symptomatic aortic stenosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Renal Infarction	New low signal intensity lesions on diffusion weighted images on MRI.	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Arwa Younis, Doctor, Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 28, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Infarction
• Other Study ID Numbers: 4887-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No