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Clinical Trials/ISRCTN56511757
ISRCTN56511757
Completed
Not Applicable

Prospective randomised trial of stented versus stentless bioprosthesis for aortic valve replacement (AVR)

Papworth Hospital NHS Trust (UK)0 sites240 target enrollmentJuly 8, 2005
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ConditionsAortic valve replacementCirculatory System

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic valve replacement
Sponsor
Papworth Hospital NHS Trust (UK)
Enrollment
240
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 8, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Papworth Hospital NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who require elective AVR with a tissue valve for symptomatic aortic valve stenosis (peak valve gradient equal to or greater than 50 mmHg as measured by echocardiography), with or without concomitant artery bypass grafting
  • •2\. Patients \= 65 years of age at the time of surgery

Exclusion Criteria

  • •1\. Patients who are already enrolled in another major cardiovascular trial
  • •2\. AVR performed primarily for aortic valve regurgitation
  • •3\. Active aortic valve infection
  • •4\. Active malignant disease
  • •5\. Renal failure requiring dialysis
  • •6\. Any previous cardiac surgery
  • •7\. The need for additional cardiac procedures other than coronary artery bypass grafting
  • •8\. Emergency operations
  • •9\. Patients unable to give informed consent

Outcomes

Primary Outcomes

Not specified

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