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Active, not recruitingNCT04112290Updated Feb 5, 2026

A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

An observational study in Hypertrophic Cardiomyopathy, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

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Conditions studied

  • Hypertrophic Cardiomyopathy

Keywords

  • Atrial fibrillation
  • Ventricular tachycardia
  • Arrhythmia
  • Hypertrophic cardiomyopathy
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In context

Cardiomyopathy, Hypertrophic

347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.

This study's planned enrollment of 260 is close to the median of 259 across 168 observational studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with hypertrophic cardiomyopathy who are participating in (or previously participated in) Mayo Clinic study 17-003514 and/or 16-009474

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Atrial fibrillation incidence in hypertrophic cardiomyopathy

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

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

  2. Atrial fibrillation recurrence in hypertrophic cardiomyopathy

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

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

  3. Ventricular arrhythmia incidence in hypertrophic cardiomyopathy

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

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

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04112290
Lead sponsor
Mayo Clinic
Collaborators
Medtronic
Responsible party
Jeffrey B. Geske (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 2, 2019
Start date
Nov 5, 2019
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Feb 5, 2026

Study contacts

Jeffrey Geske, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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