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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03701997

Enrollment

Registered

2018-10-10

Start date

2018-10-15

Completion date

2022-05-31

Last updated

2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right

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.

Interventions

DEVICEEXCOR Pediatric

Mechanical circulatory support using ventricular assist device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 21 Years

Healthy volunteers

Inclusion criteria

* Transplant eligible * Implanted with EXCOR Pediatric per IFU

Exclusion criteria

* Having any contradictions for user per IFU

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026