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

• Conditions: Aortic Valve Disease
• Interventions: Procedure: Cardiac valve surgery

• Registration Number: NCT00708409
• Lead Sponsor: University of Luebeck

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-02
• Status Verified: 2009-01
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-16
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Cardiac valve surgery	Autograft operations with the subcoronary technique
2	Cardiac valve surgery	Autograft operations with the root replacement technique

Primary Outcome Measures

Name	Time	Method
all cause reoperation rate	one year

Secondary Outcome Measures

Name	Time	Method
valve-related mortality	one year

Trial Locations

Locations (1)

University Clinic of Schleswig Holstein, Campus Luebeck; 🇩🇪 Luebeck, Germany