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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00708409
• Other study ID #: Ross-01
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 27, 2008
• Last updated: February 12, 2009
• Start date: January 2001
• Est. completion date: December 2011

Study information

• Verified date: January 2009
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and ResearchGermany: German Institute of Medical Documentation and Information
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1800
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Procedure:
• Cardiac valve surgery
Different autograft implantation techniques.

Locations

Country	Name	City	State
Germany	University Clinic of Schleswig Holstein, Campus Luebeck	Luebeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause reoperation rate		one year	No
Secondary	valve-related mortality		one year	No