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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03701997
Other study ID # EXCOR PMA Post Approval
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 15, 2018
Est. completion date May 2022

Study information

Verified date October 2018
Source Berlin Heart, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 62
Est. completion date May 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Transplant eligible

- Implanted with EXCOR Pediatric per IFU

Exclusion Criteria:

- Having any contradictions for user per IFU

Study Design


Intervention

Device:
EXCOR Pediatric
Mechanical circulatory support using ventricular assist device

Locations

Country Name City State
United States Sites per Action network Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Berlin Heart, Inc

Country where clinical trial is conducted

United States, 

Outcome

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