Characterization of Aortic Tissue at Reoperation

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

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-01-31

Brief Summary

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This study will analyse factors contributing to cardiac re-operation to determine causative effects

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Detailed Description

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This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Conditions

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Aortic Aneurysm Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Reoperation

Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects undergoing an aortic re-operation
* Subject has had BioGlue used during previous aortic surgery
* Subject is willing and able to give written informed consent for participation

Exclusion Criteria

* Subject with a history of vasculitis
* Subject with active infection (endocarditis)
* Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
* Subject with a history of auto immune disease

Eligible Sex

ALL

Accepts Healthy Volunteers

No