Pregnancy Outcomes in Patients With Adult Congenital Heart Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of Subjects with cardiovascular adverse events
- Status
- Suspended
- Last Updated
- 6 months ago
Overview
Brief Summary
The purpose of this study is to determine if a biomarker assay obtained peripartum (1st-3rd trimester and post-partum) in patients with adult congenital heart disease can predict future risk of cardiovascular adverse events and determine if temporal changes in biomarkers levels throughout the peripartum period can provide a better risk prediction compared to samples taken at a single time-point.
Investigators
Alexander C. Egbe
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Congenital Heart Disease Diagnosis
- •Currently Pregnant
Exclusion Criteria
- •Unable to consent
Outcomes
Primary Outcomes
Number of Subjects with cardiovascular adverse events
Time Frame: Baseline
A cardiovascular adverse event is defined as Documented atrial/ventricular arrhythmias, need for cardioversion, arrhythmia-related procedures (catheter ablation, implantation of pacemaker/defibrillator, anti-arrhythmia surgery), and heart failure hospitalization.
Secondary Outcomes
- Number of Subject Deaths(Baseline)