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Clinical Trials/NL-OMON43320
NL-OMON43320RecruitingNot Applicable

Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE

corlife oHG0 sites25 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
25
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
2 to 64 (—)

Inclusion Criteria

  • •1. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease.
  • •2. Informed consent of legal guardians or patients, assent of patients.

Exclusion Criteria

  • •1. The patient has not provided surveillance informed consent.
  • •2. The patient shall not suffer from
  • •a. generalized connective tissue disorders (e.g. Marfan syndrome), or
  • •b. active rheumatic disorders, or
  • •c. severe asymmetric calcification of the valve ring.
  • •3. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
  • •4. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.

Investigators

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