Trans-aortic Valve Replacement and Renal Infarction | NCT03474250

Studies
Trans-aortic Valve Replacement and Renal Infarction

NCT03474250

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

May 1, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Renal Infarction

Interventions

Magnetic Resonance test for kidney

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Feb 22, 2018

First Submission Date that Met QC Criteria

Mar 15, 2018

First Posted Date

Mar 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2018

Last Update Posted Date

May 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance test for kidney	Diagnostic Test	Magnetic Resonance test for kidney

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Hematuria	New hematuria on urine test.	one year
Elevation in Blood Pressure	Delta of more than 5%	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arwa Younis, Doctor	Contact	0544731936		or.younis@gmail.com

Overall Officials

Name	Affiliation	Role
Arwa Younis, Doctor	Tel Aviv University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided