Aortic Valve ReplacementPhase 2/3NCT01554709
Safety and Performance Study of the CardioGard Cannula
A Phase 2/3 study testing Aortic Cannulas (CardioGard) in people with Aortic Valve Replacement, run by CardioGard Medical Ltd. at 5 sites in 3 countries.
Trial summary
The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Aortic Cannulas (CardioGard)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2012to May 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
- Non pregnant female
Who cannot join
- Contraindication for open heart surgery under bypass machine
- Emergency Operation
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany2 sites
Kerckhoff Klinik
Bad Nauheim
Heart Center Leipzig, University of Leipzig
Leipzig
About this study
Official title: A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula
The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.
- Conditions
- Aortic Valve Replacement
- Being tested
- Aortic Cannulas (CardioGard)
- Keywords
- bypass, cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Cannulas (CardioGard)Device
Comparison of aortic cannulas during by pass surgery
| Study group | Role | What they receive |
|---|---|---|
| CardioGard Cannula | Experimental | Not described Receives: Device: Aortic Cannulas (CardioGard) |
| Reference Cannula | Active comparator | Not described Receives: Device: Aortic Cannulas (CardioGard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DWI- Diffusion Weighted Imaging
diffusion weighted magnetic resonance imaging (DW-MRI)
Measured: The outcome measure is assessed in average a week after the surgery
Secondary outcomes (1)
TCD- Transcranial Doppler
Measured: The Outcome measure is assessed during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioGard Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gil Bolotin, Dr., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554709
- Sponsor's protocol ID
- CLN0009
- Status last verified
- Sep 2014
- First submitted
- 11 Mar 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula
- ClinicalTrials.gov ID
- NCT01554709
- Acronym / sponsor ID
- CLN0009
- Conditions
- Aortic Valve Replacement
- Keywords
- bypass, cannula
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- CardioGard Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CardioGard Cannula | Experimental | Device: Aortic Cannulas (CardioGard) |
| Reference Cannula | Active comparator | Device: Aortic Cannulas (CardioGard) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
- Non pregnant female
Key exclusion criteria (2 listed)
- Contraindication for open heart surgery under bypass machine
- Emergency Operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic Cannulas (CardioGard)Comparison of aortic cannulas during by pass surgery | Device | CardioGard Cannula, Reference Cannula |
Primary outcome
DWI- Diffusion Weighted Imaging
Time frame: The outcome measure is assessed in average a week after the surgery
diffusion weighted magnetic resonance imaging (DW-MRI)
1 secondary outcome
TCD- Transcranial Doppler
Time frame: The Outcome measure is assessed during the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Bolotin, Dr. principal investigator
Rambam Health Care Campus
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aortic Cannulas (CardioGard) in people with Aortic Valve Replacement, run by CardioGard Medical Ltd. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DWI- Diffusion Weighted Imaging (time frame: The outcome measure is assessed in average a week after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.