Clinical trial NCT04056715: Extended ECG Monitoring in HCM Patients
Official title: Extended Ambulatory Monitoring With iRhythm Zio XT Improves Care of Patients With Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Nonsustained Ventricular Tachycardia
Ventricular Tachycardia
Atrial Fibrillation
Arrhythmia
Keywords: electrocardiography
electrocardiogram
mobile cardiac monitoring
ambulatory monitoring
ECG
EKG
Lead sponsor: iRhythm Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the hypertrophic cardiomyopathy population will be recruited.

Brief summary: The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc. Zio XT device results in identifying a greater burden of nonsustained ventricular tachyarrhythmia (nsVT) compared to current ACCF/AHA guideline recommended 48-hour monitoring.

Detailed description: Optimal duration to monitor patients for identifying nsVT remains unclear. The investigators aim to determine the prevalence and burden of nsVT with longer term monitoring with the iRhythm Zio XT device over a 2-week period vs. 48 hours; and whether, this greater burden of nsVT compared to conventional shorter monitoring potentially identifies a subset of HCM patients who may be at higher risk of sudden cardiac death.

Eligibility criteria: Inclusion Criteria:

* Subject must be 18 to 65 years of age at time of informed consent and must not be a member of a vulnerable population.
* Subject has been diagnosed with hypertrophic cardiomyopathy, as defined by a maximal LV wall thickness of ≥15 mm anywhere in LV wall, in absence of another cause that could be responsible for the LV hypertrophy.
* Subject eligible to receive the Zio XT device per the current approved indications for use.

Exclusion Criteria:

* Subject with pacemaker
* Known skin allergies or reaction to adhesives
* The investigator deems a condition that could limit a subject's ability or unwillingness to participate in the study, comply with study required monitoring and/or follow-up visits.

Primary outcomes:
measure: Total number of nsVT runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.
timeFrame: 14 days
Secondary outcomes:
measure: Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.
timeFrame: 14 days
measure: Number of clinical management decisions based on 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours ambulatory cardiac monitoring.
timeFrame: 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Martin Maron, MD
role: PRINCIPAL_INVESTIGATOR
References: