Aortic Valve DiseaseNCT03677804
Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique
An observational study of Aortic Valve Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2017to 12 Jun 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 reconstruction using autologous pericardium (OZAKI technique) in Universitätsspital Basel/ Switzerland since September 2015.
Who may be able to join
- aortic valve reconstruction using autologous Pericardium (OZAKI technique)
Who cannot join
- missing informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Herzchirurgie University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the OZAKI Technique
The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.
Read the detailed description
The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.
- Conditions
- Aortic Valve Disease
- Keywords
- aortic valve reconstruction, OZAKI technique, autologous pericardium
- Medical subject headings
- Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic transvalvular gradient measured by transthoracic echocardiography
Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography
Measured: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Secondary outcomes (3)
occurence of death
Change in clinical Parameter: death
Measured: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
occurence of cardiac re-surgery
Change in clinical parameter: cardiac re-surgery
Measured: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
occurence of stroke
Change in clinical parameter: stroke
Measured: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start2 Aug 2017
- Primary completion1 May 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies 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
- Retrospective
- Enrolment
- 35 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
- NCT03677804
- Sponsor's protocol ID
- 2017-00556; ch17Reuthebuch
- Other IDs
- 2017
- Status last verified
- Jun 2019
- First submitted
- 11 Sep 2018
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koechlin L, Schurr U, Miazza J, Imhof S, Maurer M, Erb J, Gahl B, Santer D, Berdajs D, Eckstein FS, Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.
PubMed 32458022
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the OZAKI Technique
- ClinicalTrials.gov ID
- NCT03677804
- Acronym / sponsor ID
- 2017-00556; ch17Reuthebuch
- Conditions
- Aortic Valve Disease
- Keywords
- aortic valve reconstruction, OZAKI technique, autologous pericardium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 19 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.
The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.
Detailed description
The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) in Universitätsspital Basel/ Switzerland since September 2015.
Key inclusion criteria (1 listed)
- aortic valve reconstruction using autologous Pericardium (OZAKI technique)
Key exclusion criteria (1 listed)
- missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in aortic transvalvular gradient measured by transthoracic echocardiography
Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography
3 secondary outcomes
occurence of death
Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
occurence of cardiac re-surgery
Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
occurence of stroke
Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac 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 13 Jun 2019.
- Derived from this study: PubMed 32458022Koechlin L, Schurr U, Miazza J, Imhof S, Maurer M, Erb J, Gahl B, Santer D, Berdajs D, Eckstein FS, Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.
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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.
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 Disease, 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 1 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 Jun 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?
Change in aortic transvalvular gradient measured by transthoracic echocardiography (time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677804, which also lists 1 linked publication.
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 Jun 2019.