Prospective Long-Term Outcomes of a Standardized Ross Procedure
ConditionAortic Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBaylor Research Institute
About this trial
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.
Disqualifiers
Less than 18 years of age
Presence of active malignancy
Pregnant at the time of surgery
Inability to provide informed consent
Trial population
Eligible patients undergoing the Ross procedure at the four institutions of the NARC will be included in this study. The primary study center will be Baylor Scott and White The Heart Hospital. The other member institutions include: The University of Pennsylvania, The University of Washington, and Northwestern University. The investigators estimate to enroll around 20 subjects per year at each institution. This will total 80 subjects per year. The investigators plan to enroll patients for 10 years during the duration of the study. The investigators plan to follow patients for their lifetime.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Survival of the patient
The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.
Time frame
1 year, 5 year and 10 yearSecondary outcomes
1
Rate of re-hospitalization
To identify the safety of the Ross procedure measured in percentage
Time frame
1 year after the procedure2
Rate of peri operative morbidity
Will be measured in percentage
Time frame
1 year after the procedure3
Rate of re-operation
Will be measured in percentage
Time frame
1 year after the procedure4
Rate of re-intervention
will be measured in percentage
Time frame
1 year after the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov