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NCT04112290 Clinical Trial

A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

Official title:
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04112290
Other study ID # 17-011376
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2019
Est. completion date December 2027

Study information
Verified date January 2024
Source Mayo Clinic
Contact Nicholas Wozniak
Phone 507-255-8794
Email Wozniak.Nicholas@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 260
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Medtronic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Atrial fibrillation incidence in hypertrophic cardiomyopathy Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Primary Atrial fibrillation recurrence in hypertrophic cardiomyopathy Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
Primary Ventricular arrhythmia incidence in hypertrophic cardiomyopathy Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
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