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

• Conditions: Ventricular Dysfunction; Ventricular Dysfunction, Left; Ventricular Dysfunction, Right
• Interventions: Device: EXCOR Pediatric

• Registration Number: NCT03701997
• Lead Sponsor: Berlin Heart, Inc

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.

Detailed Description

The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Last Update Submitted: 2018-10-09
• Study First Posted: 2018-10-10
• Last Update Posted: 2018-10-10
• Study Start: 2018-10-15
• Primary Completion: 2021-12
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Transplant eligible
• Implanted with EXCOR Pediatric per IFU

Exclusion Criteria

• Having any contradictions for user per IFU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EXCOR Pediatric	EXCOR Pediatric	Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric

Primary Outcome Measures

Name	Time	Method
Stroke rate	Until discontinuation of device support or 180 days	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%.

Secondary Outcome Measures

Name	Time	Method
Device effectiveness	Until discontinuation of device support or 180 days	Proportion of subjects experiencing a successful (transplant, wean for recovery) outcome
Adverse Events	Until discontinuation of device support or 180 days	Adverse Event rates per patient-month

Trial Locations

Locations (1)

Sites per Action network; 🇺🇸 Cincinnati, Ohio, United States