- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677804
Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique
June 12, 2019 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, 4031
- Herzchirurgie University Hospital Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) in Universitätsspital Basel/ Switzerland since September 2015.
Description
Inclusion Criteria:
- aortic valve reconstruction using autologous Pericardium (OZAKI technique)
Exclusion Criteria:
- missing informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurence of death
Time Frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
|
Change in clinical Parameter: death
|
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
|
Change in clinical parameter: cardiac re-surgery
|
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
|
Change in clinical parameter: stroke
|
From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Oliver Reuthebuch, PD Dr. med, University Hospital, Basel, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2017
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
June 12, 2019
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Actual)
June 13, 2019
Last Update Submitted That Met QC Criteria
June 12, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00556; ch17Reuthebuch
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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