UnknownNot Applicable

Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

United States62 participantsStarted 2018-10-15

Plain-language summary

The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (\<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.

Who can participate

Age range1 Day – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Transplant eligible * Implanted with EXCOR Pediatric per IFU Exclusion Criteria: * Having any contradictions for user per IFU

What they're measuring

Stroke rate

Timeframe: Until discontinuation of device support or 180 days

Trial details

NCT IDNCT03701997

SponsorBerlin Heart, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12

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