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Clinical Trials/CTRI/2022/08/044557
CTRI/2022/08/044557
Recruiting
未知

Prospective, Multi-centric Registry to evaluate the Safety and Effectiveness of Aortic Valve Bio Prosthesis â?? Indian InspiRis RegIStry -IIRIS

SRM Institutes for Medical Science SIMS0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: I358- Other nonrheumatic aortic valve disorders

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: I358- Other nonrheumatic aortic valve disorders
Sponsor
SRM Institutes for Medical Science SIMS
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Observational

Investigators

Sponsor
SRM Institutes for Medical Science SIMS

Eligibility Criteria

Inclusion Criteria

  • •1\.Patient who have undergone aortic valve replacement with Edwards Inspiris Resilia
  • •(EIR) in aortic position either of aortic stenosis/ aortic regurgitation.
  • •2\. Patient who have undergone concomitant procedure along with Aortic valve
  • •replacement with EIR.
  • •3\. Age: Above 18 years, both genders.
  • •4\. Subject undergoing redo AVR surgery due to previous mechanical/ bioprosthetic valve
  • •dysfunction/thrombosis (due to non\-compliance to anti\-coagulation medication)
  • •5\. Child\-bearing age female patients planning pregnancy
  • •6\. Those who are willing to provide consent.

Exclusion Criteria

  • •1\.Infective Endocarditis
  • •2\.Paediatric and Congenital Heart Disease

Outcomes

Primary Outcomes

Not specified

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