Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases

Mayo Clinic300 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Tetralogy of Fallot Congenital Heart Disease

Interventions

Remote Heart Rhythm MonitoringDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Right Heart Remodeling

Right Heart Remodeling measured via right atrial reservoir strain (%).

Time frame: 24 Months

Secondary Outcomes

Incident arrhythmias

Incident of atrial flutter, atrial fibrillation, atrial tachycardia, and/or ventricular tachycardia.

Time frame: 24 Months

Aerobic Capacity

Aerobic Capacity measured as maximal oxygen consumption (ml/kg/min).

Time frame: 24 Months

Central Contacts

Halley Davison

CONTACT

507-422-6246 RSTACHDRESPRG@mayo.edu

Data from ClinicalTrials.gov

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