Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
1 other identifier
observational
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 10, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedOctober 10, 2018
October 1, 2018
3.1 years
October 9, 2018
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Stroke rate
The primary endpoint is to demonstrate that the rate of stroke (ischemic or hemorrhagic) will be no worse than the pre-specified performance goal. The rate will be calculated as the proportion of subjects experiencing a stroke while on EXCOR® Pediatric support within the first 180 days post-implant. The upper bound of the 95% confidence interval for the observed stroke rate will be compared to the pre-specified performance goal of 30%.
Until discontinuation of device support or 180 days
Secondary Outcomes (2)
Adverse Events
Until discontinuation of device support or 180 days
Device effectiveness
Until discontinuation of device support or 180 days
Study Arms (1)
EXCOR Pediatric
Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
Interventions
Mechanical circulatory support using ventricular assist device
Eligibility Criteria
Pediatric (0-21 years) who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
You may qualify if:
- Transplant eligible
- Implanted with EXCOR Pediatric per IFU
You may not qualify if:
- Having any contradictions for user per IFU
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sites per Action network
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert M Kroslowitz, BS
Berlin Heart, Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Post-Marketing Study
- Yes
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 10, 2018
Study Start
October 15, 2018
Primary Completion
December 1, 2021
Study Completion
May 1, 2022
Last Updated
October 10, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share