A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Currently or previously enrolled in 17-003514 and 16-009474
Adults age >18 years-old with a diagnosis of hypertrophic cardiomyopathy
Both sexes
Able to consent

Exclusion criteria

Vulnerable study population
Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
Pacemaker/ICD implantation
Pregnancy

Treatment and study plan

Primary outcomes

Atrial fibrillation incidence in hypertrophic cardiomyopathy

Time frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.

Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Atrial fibrillation recurrence in hypertrophic cardiomyopathy

Time frame: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.

Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Ventricular arrhythmia incidence in hypertrophic cardiomyopathy

Time frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.

Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Medtronic

Registry information

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2027
First posted: Oct 2, 2019
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.

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

Completed