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

Ventricular Dysfunction Clinical Trial

Official title:

All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03701997
• Other study ID #: EXCOR PMA Post Approval
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

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

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