Aortic Valve Surgery10vs20-OZAKINCT03667235
10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
An observational study of Aortic Valve Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Surgery
- What is being tested?
- Treatment of human pericardium with glutaraldehyde in OZAKI procedure and Treatment of human aortic valve tissue with glutaraldehyde
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Aug 2017to 31 Oct 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland
Who may be able to join
- patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)
Who cannot join
- denial of consent
- insufficient leftover tissues from the OZAKI procedure
- patients after thoracic radiation or surgery
Trial locations and contacts
1 site in 1 country.
About this study
To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes
Read the detailed description
Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).
This study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.
To investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.
- Conditions
- Aortic Valve Surgery
- Being tested
- Treatment of human pericardium with glutaraldehyde in OZAKI procedure, Treatment of human aortic valve tissue with glutaraldehyde
- Keywords
- OZAKI technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of human pericardium with glutaraldehyde in OZAKI procedureOther
10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure
Treatment of human aortic valve tissue with glutaraldehydeOther
10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanic stability tests to investigate uniaxial and cyclical tensile properties
mechanical tests include the use of a universal test machine (MTS Bionix, Department of Bioengineering of Universitaetsspital Basel) for:
- uniaxial ultimate tensile strength (UTS) test;
- cyclical tensile stretching of the tissue in order to investigate its viscoelastic properties
Measured: 4 days after surgery
thermic stability by using constant force at linearly increasing temperature
constant force at linearly increasing temperature: Thermal stability tests will be conducted on 20 x 4 mm stripes by the imposition of a constant load (approximately 1N) submerged in a saline-solution bath. The temperature of the bath will be increased at a rate of approximately 2.5-5 °C/min, and the sample cross-section will be measured by means of a high-resolution camera (Canon EOS, Japan)
Measured: 4 days after surgery
Secondary outcomes (2)
histologic analysis of collagen fiber organization and quantification
histologic analysis by Scanning Electrical Microscopy (SEM) and using Picrosirius staining to identify the types I and IV collagen
Measured: 4 days after surgery
Pronase testing to analyse enzymatic degradation
Pronase testing to analyse enzymatic degradation
Measured: 4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start4 Aug 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, PD Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667235
- Sponsor's protocol ID
- 2017-01334; ch17Reuthebuch2
- Other IDs
- 2017
- Acronym
- 10vs20-OZAKI
- Status last verified
- Dec 2019
- First submitted
- 10 Sep 2018
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
- ClinicalTrials.gov ID
- NCT03667235
- Acronym / sponsor ID
- 10vs20-OZAKI / 2017-01334; ch17Reuthebuch2
- Conditions
- Aortic Valve Surgery
- Keywords
- OZAKI technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- 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.
To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes
Detailed description
Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).
This study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.
To investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland
Key inclusion criteria (1 listed)
- patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)
Key exclusion criteria (3 listed)
- denial of consent
- insufficient leftover tissues from the OZAKI procedure
- patients after thoracic radiation or 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 |
|---|---|---|
| Treatment of human pericardium with glutaraldehyde in OZAKI procedure10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure | Other | – |
| Treatment of human aortic valve tissue with glutaraldehyde10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde | Other | – |
Primary outcome
mechanic stability tests to investigate uniaxial and cyclical tensile properties
Time frame: 4 days after surgery
mechanical tests include the use of a universal test machine (MTS Bionix, Department of Bioengineering of Universitaetsspital Basel) for: * uniaxial ultimate tensile strength (UTS) test; * cyclical tensile stretching of the tissue in order to investigate its viscoelastic properties
thermic stability by using constant force at linearly increasing temperature
Time frame: 4 days after surgery
constant force at linearly increasing temperature: Thermal stability tests will be conducted on 20 x 4 mm stripes by the imposition of a constant load (approximately 1N) submerged in a saline-solution bath. The temperature of the bath will be increased at a rate of approximately 2.5-5 °C/min, and the sample cross-section will be measured by means of a high-resolution camera (Canon EOS, Japan)
2 secondary outcomes
histologic analysis of collagen fiber organization and quantification
Time frame: 4 days after surgery
Pronase testing to analyse enzymatic degradation
Time frame: 4 days after 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 10 Dec 2019.
Related trials for Aortic Valve Surgery
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Aortic Valve Stenosis
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA)
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.
Oliver Reuthebuch, PD Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 3 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 10 Dec 2019. 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 Switzerland. 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?
mechanic stability tests to investigate uniaxial and cyclical tensile properties (time frame: 4 days after surgery). The study lists 2 primary outcomes in all. 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 10 Dec 2019.