Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)

Study Overview
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Brief Summary
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With the current knowledge of aortic valve replacement modalities, no specific recommendations can be given and the decision for a particular prosthesis or procedure is rather arbitrarily. The investigators hypothesize that the autograft procedure according to Ross is superior in terms of hemodynamic (especially regression of left ventricular hypertrophy) and major adverse valve related events even in a long-term course

Detailed Description
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For patients with aortic valve disease requiring surgical treatment several options are available. In some instances the valve can be repaired, however replacement of the valve is usually necessary. The choice for a particular aortic valve replacement procedure is influenced by several inter-related factors (e.g. prosthesis, procedure itself, patient age, concomitant disease, atrial fibrillation, center's experience, and preference of the referring cardiologist, the attending surgeon and the patient). Often, more than one type of prosthesis seems suitable for the individual patient, whereby the decision for a particular prosthesis is made rather arbitrarily. With the current knowledge on outcome of patients after aortic valve replacement with different types of prosthesis (pulmonary autograft according to Ross, bioprosthesis, mechanical heart valve), no specific recommendation can be given. This is especially true for the autograft, since no long-term outcome is yet available from clinical practice. In 2001 the German Ross Registry was established by our working group. Although the Ross procedure was expected to be a lifelong solution for aortic valve disease, it seemed appropriate to make a collaborative effort to establish a multicenter long term follow-up study to examine longitudinal clinical outcomes associated with the procedure, as well as, attempt to resolve and identify the many technical considerations necessary for successful execution of the procedure. With these issues in mind, we have already included about 1400 Ross operated patients from nine participating centers into the registry with up to fourteen years follow-up. The first release of an annual report was presented in February 2004. The main limitation of this Registry is the limited maximal time span of follow-up keeping in mind that the next years of the follow-up are most important for evaluating the Ross procedure because possible degeneration of the aortic valve substitute may occur. Therefore long-term observation is required.

Official Title
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Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)-the German-Dutch- Ross Registry

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Procedure: Cardiac valve surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the need for aortic valve replacement, aortic valve replacement in the young with the need of valve growth potential, contraindication to oral anticoagulation therapy, female patients with the wish of childbearing, Exclusion Criteria: Extensive coronary artery disease, extensive aortic root calcification, severely impaired left ventricular function, failure to provide informed consent, current participation in another clinical trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Autograft operations with the subcoronary technique | Procedure: Cardiac valve surgery<br>* Different autograft implantation techniques.<br>* Other names: Ross operation, autograft, homograft;|
| 2<br>Autograft operations with the root replacement technique | Procedure: Cardiac valve surgery<br>* Different autograft implantation techniques.<br>* Other names: Ross operation, autograft, homograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause reoperation rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| valve-related mortality |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ross operation, autograft procedure, pulmonary homograft, root replacement technique, subcoronary implantation technique