NCT01554709

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

March 11, 2012

Last Update Submit

September 23, 2014

Conditions

Aortic Valve Replacement

Keywords

bypasscannula

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • TCD- Transcranial Doppler

    The Outcome measure is assessed during the surgery

Study Arms (2)

CardioGard Cannula

EXPERIMENTAL
Device: Aortic Cannulas (CardioGard)

Reference Cannula

ACTIVE COMPARATOR
Device: Aortic Cannulas (CardioGard)

Interventions

Aortic Cannulas (CardioGard)DEVICE

Comparison of aortic cannulas during by pass surgery

CardioGard CannulaReference Cannula

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication for open heart surgery under bypass machine
  • Emergency Operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kerckhoff Klinik

Bad Nauheim, Germany

Location

Heart Center Leipzig, University of Leipzig

Leipzig, Germany

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Insel Hospital

Bern, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Study Officials

  • Gil Bolotin, Dr.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2012

First Posted

March 15, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

CH(2)DE(2)IL(1)