Congenital Heart Disease, Tetralogy of Fallot
Conditions
Brief summary
This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)
Interventions
DIAGNOSTIC_TESTRemote Heart Rhythm Monitoring
We will be looking to see if remote heart rhythm monitoring for 30 days at baseline, 12, and 24 months, helps for early identification of adverse cardiac events.
Sponsors
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate (or greater) PR based on quantitative Doppler echocardiography. * Repaired TOF * Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.
Exclusion criteria
* Pregnant Women * Unable to undergo CMRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Right Heart Remodeling | 24 Months | Right Heart Remodeling measured via right atrial reservoir strain (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incident arrhythmias | 24 Months | Incident of atrial flutter, atrial fibrillation, atrial tachycardia, and/or ventricular tachycardia. |
| Aerobic Capacity | 24 Months | Aerobic Capacity measured as maximal oxygen consumption (ml/kg/min). |
Countries
United States
Contacts
CONTACTHalley Davison
PRINCIPAL_INVESTIGATORAlexander Egbe, MBBS, MPH
Mayo Clinic
Outcome results
None listed