Safety and Performance Study of the CardioGard Cannula | NCT01554709

Studies
Safety and Performance Study of the CardioGard Cannula

NCT01554709

Sponsor

CardioGard Medical Ltd.

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

71Actual

Phase

Phase 2Phase 3

Conditions

Aortic Valve Replacement

Interventions

Aortic Cannulas (CardioGard)

Countries

Germany
Israel
Switzerland

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Mar 11, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 15, 2012Estimated

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

Sep 23, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CardioGard Cannula	Experimental		Device: Aortic Cannulas (CardioGard)
Reference Cannula	Active Comparator		Device: Aortic Cannulas (CardioGard)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aortic Cannulas (CardioGard)	Device	Comparison of aortic cannulas during by pass surgery	CardioGard Cannula Reference Cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DWI- Diffusion Weighted Imaging	diffusion weighted magnetic resonance imaging (DW-MRI)	The outcome measure is assessed in average a week after the surgery

Secondary Outcomes

Measure	Description	Time Frame
TCD- Transcranial Doppler		The Outcome measure is assessed during the surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
Non pregnant female

Exclusion Criteria:

Contraindication for open heart surgery under bypass machine
Emergency Operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gil Bolotin, Dr.	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kerckhoff Klinik		Bad Nauheim			Germany
Heart Center Leipzig, University of Leipzig