Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05122962

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tetralogy of Fallot Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Alexander Egbe, MBBS, MPH

PRINCIPAL_INVESTIGATOR

Halley Davison

CONTACT

[email protected]

507-422-6246

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Heart Rhythm Monitoring

Diagnostic 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.

Primary outcomes

  1. Right Heart Remodeling

    Time frame: 24 Months

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

Secondary outcomes

  1. Incident arrhythmias

    Time frame: 24 Months

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

  2. Aerobic Capacity

    Time frame: 24 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Halley Davison

CONTACT

[email protected]

507-422-6246

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: PACT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2021
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.