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

October 9, 2018 updated by: Berlin Heart, Inc

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Sites per Action network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric (0-21 years) who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric

Description

Inclusion Criteria:

  • Transplant eligible
  • Implanted with EXCOR Pediatric per IFU

Exclusion Criteria:

  • Having any contradictions for user per IFU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EXCOR Pediatric
Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
Device: EXCOR Pediatric
Mechanical circulatory support using ventricular assist device
Other Names:
  • EXCOR Pediatric VAD
  • EXCOR Pediatric Ventricular Assist Device
  • Berlin Heart EXCOR Pediatric
  • EXCOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke rate
Time Frame: 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%.
Until discontinuation of device support or 180 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berlin Heart, Inc

Investigators

  • Study Director: Robert M Kroslowitz, BS, Berlin Heart, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2018

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXCOR PMA Post Approval

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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