Aortic Xenograft HemodynamicsNCT03021356
Comparison of TrIfecta and Perimount Magna Ease
A study testing Aortic xenograft in people with Aortic Xenograft Hemodynamics, run by Kerckhoff Klinik at 1 site in Germany.
Trial summary
The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Xenograft Hemodynamics
- What is being tested?
- Aortic xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Aug 2016
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 75 years
- Elective aortic valve replacement in patients with predominant aortic stenosis
- including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
- Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
- Native German speakers (quality of life questionnaire in German language)
Who cannot join
- Isolated aortic regurgitation
- Concomitant aortic regurgitation > 2°
- Endocarditis
- LVEF <40%
- Concomitant other valve surgery
- s/p valve surgery
- Contraindication for stress echocardiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease
The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.
- Conditions
- Aortic Xenograft Hemodynamics
- Being tested
- Aortic xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic xenograftDevice
After randomization, the aortic xenograft is implanted in the standard fashion
| Study group | Role | What they receive |
|---|---|---|
| Trifecta aortic xenograft | Active comparator | The Trifecta aortic xenograft is implanted in these patients. Receives: Device: Aortic xenograft |
| Magna Ease aortic xenograft | Active comparator | The Magna Ease aortic xenograft is implanted in these patients. Receives: Device: Aortic xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transprosthetic pressure gradient at stress exercise echocardiography
Measured: Echo at follow up stress echo (at 10 months)
Secondary outcomes (4)
Transprosthetic pressure gradient at discharge echo
Measured: Echo at discharge (usually postoperative day 5 to 7)
Left ventricular mass regression calculated by echocardiography (gram)
Measured: Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)
Quality of life using the EQ-5D-3L questionnaire
Measured: 1 to 5 days before surgery and at follow up (10 months)
BNP plasma level
Measured: 1 to 5 days before surgery and at follow up (10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Xenograft HemodynamicsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerckhoff Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021356
- Sponsor's protocol ID
- COTRIP
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease
- ClinicalTrials.gov ID
- NCT03021356
- Acronym / sponsor ID
- COTRIP
- Conditions
- Aortic Xenograft Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kerckhoff KlinikUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Jan 2017 (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 hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifecta aortic xenograft | Active comparator | Device: Aortic xenograftThe Trifecta aortic xenograft is implanted in these patients. |
| Magna Ease aortic xenograft | Active comparator | Device: Aortic xenograftThe Magna Ease aortic xenograft is implanted in these patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 18 and 75 years
- Elective aortic valve replacement in patients with predominant aortic stenosis
- Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
- Native German speakers (quality of life questionnaire in German language)
Key exclusion criteria (7 listed)
- Isolated aortic regurgitation
- Concomitant aortic regurgitation > 2°
- Endocarditis
- LVEF <40%
- Concomitant other valve surgery
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 xenograftAfter randomization, the aortic xenograft is implanted in the standard fashion | Device | Magna Ease aortic xenograft, Trifecta aortic xenograft |
Primary outcome
Transprosthetic pressure gradient at stress exercise echocardiography
Time frame: Echo at follow up stress echo (at 10 months)
4 secondary outcomes
Transprosthetic pressure gradient at discharge echo
Time frame: Echo at discharge (usually postoperative day 5 to 7)
Left ventricular mass regression calculated by echocardiography (gram)
Time frame: Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)
Quality of life using the EQ-5D-3L questionnaire
Time frame: 1 to 5 days before surgery and at follow up (10 months)
BNP plasma level
Time frame: 1 to 5 days before surgery and at follow up (10 months)
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 13 Jan 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic xenograft in people with Aortic Xenograft Hemodynamics, run by Kerckhoff Klinik at 1 site in Germany.
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 5 inclusion and 7 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Transprosthetic pressure gradient at stress exercise echocardiography (time frame: Echo at follow up stress echo (at 10 months)). 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 13 Jan 2017.