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Clinical Trials/NL-OMON53079
NL-OMON53079
Recruiting
Not Applicable

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement - Medtronic TAVR System In Patients at Low Risk for SAVR

Medtronic B.V.0 sites60 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medtronic B.V.
Enrollment
60
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Heart Team consensus patient has \< 3% predicted risk of mortality at 30 days
  • •\* Severe aortic stenosis, defined as :
  • •\* Symptomatic aortic stenosis
  • •Aortic valve area \<\= 1\.0 cm2 (or aortic valve area index of \<\= 0\.6 cm2/m2\), OR
  • •gradient \>\= 40 mmHg, OR maximal aortic valve velocity \>\= 4\.0 m/sec by
  • •transthoracic echocardiography
  • •\* Asymptomatic aortic stenosis:
  • •\- Very severe aortic stenosis with an aortic valve area of \<\=1\.0 cm2 (or aortic
  • •valve area index of \<\=0\.6 cm2/m2\), AND maximal aortic velocity \>\= 5\.0 m/sec,
  • •or mean gradient \>\= 60 mmHg by transthoracic echocardiography, OR

Exclusion Criteria

  • •Bicuspid aortic valve identified by echocardiography, MDCT, or Magnetic
  • •Significant ascending aortopathy

Outcomes

Primary Outcomes

Not specified

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