ClinicalTrials.gg
Status unknownNCT03474250Updated May 1, 2018

Trans-aortic Valve Replacement and Renal Infarction

An observational study in Renal Infarction, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Renal Infarction

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03

In context

Infarction

71 studies on the registry are indexed under Infarction; 15 are open to participants now.

This study's planned enrollment of 20 is below the median of 119 across 23 observational studies indexed under Infarction.

Browse Infarction studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testMagnetic Resonance test for kidney

    Magnetic Resonance test for kidney

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What researchers measure

Primary outcomes

  1. New Renal Infarction

    New low signal intensity lesions on diffusion weighted images on MRI.

    Time frame: one year

Secondary outcomes

  1. Hematuria

    New hematuria on urine test.

    Time frame: one year

  2. Elevation in Blood Pressure

    Delta of more than 5%

    Time frame: one year

  3. Elevation in Plasma Renin Activity

    Delta of more than 5%

    Time frame: one year

  4. Elevation in Aldosteron level

    Delta of more than 5%

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Sheba Medical Center
    Ramat Gan, Israel
    Recruiting
    • Arwa Younis, Doctor · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03474250
Responsible party
Prof. Amit Segev (Proffesor, Sheba Medical Center) — Principal investigator
First posted
Mar 22, 2018
Start date
Apr 1, 2018
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
May 1, 2018

Study contacts

Arwa Younis, Doctor
Contact
or.younis@gmail.com
0544731936
Arwa Younis, Doctor
principal investigator · Tel Aviv University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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