Safety and Performance Study of the CardioGard Cannula

NCT ID: NCT01554709

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CardioGard Cannula

Group Type EXPERIMENTAL

Aortic Cannulas (CardioGard)

Intervention Type DEVICE

Comparison of aortic cannulas during by pass surgery

Reference Cannula

Group Type ACTIVE_COMPARATOR

Aortic Cannulas (CardioGard)

Intervention Type DEVICE

Comparison of aortic cannulas during by pass surgery

Interventions

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Aortic Cannulas (CardioGard)

Comparison of aortic cannulas during by pass surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioGard Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gil Bolotin, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status

Heart Center Leipzig, University of Leipzig

Leipzig, , Germany

Site Status

Rambam Health Care Campus

Haifa, , Israel

Site Status

Insel Hospital

Bern, , Switzerland

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Germany Israel Switzerland

Other Identifiers

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CLN0009

Identifier Type: -

Identifier Source: org_study_id

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