Safety and Performance Study of the CardioGard Cannula

CardioGard Medical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Aortic Valve Replacement

Treatments: Device: Aortic Cannulas (CardioGard)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01554709

CLN0009

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups

CardioGard Cannula

Experimental group

Treatment:

Device: Aortic Cannulas (CardioGard)

Reference Cannula

Active Comparator group

Treatment:

Device: Aortic Cannulas (CardioGard)