Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant Women
Unable to undergo CMRI
Trial population
This will be a prospective study of patients with congenital heart disease receiving care at Mayo Clinic Rochester, MN.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Remote Heart Rhythm Monitoring
Diagnostic testWe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Right Heart Remodeling
Right Heart Remodeling measured via right atrial reservoir strain (%).
Time frame
24 MonthsSecondary outcomes
1
Incident arrhythmias
Incident of atrial flutter, atrial fibrillation, atrial tachycardia, and/or ventricular tachycardia.
Time frame
24 Months2
Aerobic Capacity
Aerobic Capacity measured as maximal oxygen consumption (ml/kg/min).
Time frame
24 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov