Advanced Cardiac Therapies Improving Outcomes Network to Improve the Health of Pediatric and Congenital Heart Disease Patients with Heart Failure
John Parent, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
Our goal is to partner with patients who have heart failure and their families to achieve improved outcomes and quality of life. In addition, the network will provide an ideal platform for clinical, translational, and comparative effectiveness research.
Detailed description of study
What will happen during the study?
Phase 1 Registry data collection
Action has established an initial registry that will capture the data elements needed to study all children and congenital heart disease patients that are treated with a VAD. This registry will require manual entry of data into a secure password protected web based portal to allow Action to begin working on both quality improvement and research initiatives focused on the care of patients that require a VAD. Collected variables include patient demographics (race, ethnicity, date of birth, gender), details about the admission and VAD implant, and data collected at follow-up visits including collection of adverse events and outcomes.
Phase 2 Registry data collection
Action will enhance the registry to capture all data elements needed to study all children and congenital heart disease patients that are admitted to the hospital with heart failure. Action will work on both quality improvement and research initiatives focused on the care of all patients with heart failure, not only those that require VAD implantation. Collected variables include patient demographics (race, ethnicity, date of birth, gender), details about diagnosis, and data collected at clinic visits including collection of adverse events and outcomes.
All Phases
This registry will contain a retrospective component. This portion of the registry will be collecting data from January 1, 2012 until April 1, 2018. If any data will be collected after April 1, 2018, consent will be obtained if the data is to be used for research purposes.
The registry has been built and will be hosted by a third party (Simplified Clinical Data Systems). The registry platform is Code of Federal Regulations Title 21 compliant.
Each patient participant enrolled at a care center will be assigned a registry-specific study identifier at the time of VAD implantation or in phase 2 at hospital admission for heart failure. This identifier will be used to record routine follow-up visit information for the patient.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Congential Heart Disease, Heart Failure, VAD, Riley
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Age: 100 years or below
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Gender: All
Inclusion Criteria (Phase 1):
Patients implanted with a VAD (durable or temporary) or a total artificial heart at an Action site. Each VAD that a patient receives will require an additional implant CRF and follow up. Patients with a temporary VAD and oxygenator can be included.
Inclusion Criteria (Phase 2):
Patient admitted to the hospital with heart failure as admitting diagnosis, regardless of etiology. These patients must require inpatient heart failure management.
Exclusion Criteria (Phase 1 only):
Patients on standard ECMO as only support strategy.
