Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases
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| ClinicalTrials.gov Identifier: NCT04816851 |
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Recruitment Status :
Recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
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Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients. A very promising technique with the potential benefits of dodging oral anticoagulation, foreign material, and suitable for patients with small aortic annuli and in infectious endocarditis.
Performing hemodynamic evaluation, assess the clinical implementation and report preliminary results at follow up .
| Condition or disease | Intervention/treatment |
|---|---|
| Aortic Valve Disease | Procedure: OZAKI technique |
Heart valve disease signifies a severe growing public health problem in developing countries, with aortic valve stenosis being the most common issue. Heart valve disease is commonly initiated by atherosclerotic degenerative processes, congenital anomalies, or rheumatic process. Aortic valve replacement is the gold standard in the treatment of patients with severe aortic stenosis and aortic regurgitation. Mechanical valves are favoured in younger patients (<60 years) owing to longer life-time, whereas biological valves are used for elderly patients in order to evade oral anticoagulation.
Options for aortic valve disease have improved in the last era including replacement, repair, and reconstructive options. A variety of creative techniques including leaflet extensions, neo-leaflet creation, resuspension or plication of prolapsing leaflets, and commissuroplasty to repair valves have been officially become skilled at, specially in pediatric population . In adults, the introduction of trans-catheter aortic valve inserting now permits treatment of degenerative aortic stenosis in the oldest and the highest risk patients. However, surgical treatment choices for pediatric patients with complex congenital aortic valve disease stay restricted.
In recent years, much attention has been given to the Ozaki procedure, an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision.
| Study Type : | Observational |
| Estimated Enrollment : | 1 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Autologous Pericardial Tricuspid Reconstruction of Aortic Valve Leaflets (Ozaki Procedure) in Aortic Valve Diseases |
| Estimated Study Start Date : | March 30, 2021 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | July 30, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Ozaki group
Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.
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Procedure: OZAKI technique
an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision. |
- aortic transvalvular gradient [ Time Frame: at follow up frame through one year ]analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography
- Duration of hospitalization [ Time Frame: average 5-7 days ]number of days spent
- number of patients developed complications [ Time Frame: through one year ]the study will be monitored for Endocarditis, thromboembolic manifestation, intracranial hemorrhage
- conduction disturbances [ Time Frame: 6 months post operative ]the patients will be monitored for arrhythmia
- aortic valve re intervention or aortic regurge [ Time Frame: through one year ]analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography
- LV dimensions and EF%. [ Time Frame: through one year ]Follow up Echocardiography data such as LV dimensions and EF%.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subject with AV disease.
- Documented symptomatic moderate or greater aortic stenosis
- small aortic annulus patients
- A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.
- Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis.
- Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.
Exclusion Criteria:
- Patients with previous aortic valve surgery.
- missing informed consent
- Participation in another clinical research.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816851
| Contact: Mohammed Emad Eldin Omar | 02010065327099 | mhmd_rabab@yahoo.com | |
| Contact: Mohamed Alaa Nady, PHD | 0201006764292 | alaa_nady79@yahoo.com |
| Egypt | |
| Assiut university | Recruiting |
| Assiut, Egypt | |
| Principal Investigator: | Ali Abd Elwahab, PHD | Assiut University |
| Responsible Party: | Mohammed Emad El-Dein Omar, specialist, Assiut University |
| ClinicalTrials.gov Identifier: | NCT04816851 |
| Other Study ID Numbers: |
17200559 |
| First Posted: | March 25, 2021 Key Record Dates |
| Last Update Posted: | March 25, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Aortic Valve Disease Heart Defects, Congenital Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |