Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU (ORVAS)
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|ClinicalTrials.gov Identifier: NCT03259945|
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients.
Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.
The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time.
More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.
However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject.
The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.
|Condition or disease||Intervention/treatment|
|Patients With a Sutureless Aortic Valve||Other: Data collection Other: Review of ECGs|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||December 2019|
- Other: Data collection
demographic and clinical data
- Other: Review of ECGs
nature and frequency of proven conduction disorders
- presence of conduction disorders on postoperative ECGs [ Time Frame: through study completion, an average of 2 years ]
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): NCT03259945
|Chu Dijon Bourgogne||Recruiting|
|Dijon, France, 21000|
|Contact: Olivier BOUCHOT 0380293352 OLIVIER.BOUCHOT@CHU-DIJON.FR|