Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
NCT ID: NCT03701997
Last Updated: 2018-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
62 participants
OBSERVATIONAL
2018-10-15
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
NCT00583661
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
NCT05610787
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
NCT01242891
EXCOR® Pediatric VAD Anticoagulation IDE
NCT03702192
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
NCT00483197
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EXCOR Pediatric
Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
EXCOR Pediatric
Mechanical circulatory support using ventricular assist device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EXCOR Pediatric
Mechanical circulatory support using ventricular assist device
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Implanted with EXCOR Pediatric per IFU
Exclusion Criteria
1 Day
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Berlin Heart, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert M Kroslowitz, BS
Role: STUDY_DIRECTOR
Berlin Heart, Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sites per Action network
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EXCOR PMA Post Approval
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.