Trial Outcomes & Findings for A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System (NCT NCT04723355)

Last Updated: 2024-10-24

Results Overview

Number of patients with cardiac arrhythmias detected in both Holter monitors, including a) atrial fibrillation or atrial flutter; b) supraventricular tachycardia (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter); c) ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation); d) polymorphic ventricular tachycardia or ventricular fibrillation; e) atrioventricular (AV) block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 2nd degree AV block Mobitz type I and II, AV block 2:1 or complete AV block); or f) heart beat pauses (≥ 2,5 seconds)

Recruitment status

COMPLETED

Study phase

Target enrollment

231 participants

Primary outcome timeframe

24 hours

Results posted on

2024-10-24

Participant Flow

Individuals attending the study inclusion criteria were consecutively approached to participate in the study between 26 January 2021 and 16 November 2021 at the arrhythmia clinic of the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil

Participant milestones

Participant milestones
Measure	Holter Device In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Overall Study STARTED	231
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Holter Device In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Overall Study Issues with leads off, substantial ECG signal artefacts, and ECG data upload errors	50
Overall Study Errors in the informed consent form	2

Baseline Characteristics

A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Age, Continuous	58.4 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	113 Participants n=5 Participants
Race/Ethnicity, Customized Race · Mixed	35 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	29 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants
Region of Enrollment Brazil	179 participants n=5 Participants
Marital status Married	115 Participants n=5 Participants
Marital status Single	30 Participants n=5 Participants
Marital status Divorced	19 Participants n=5 Participants
Marital status Widowed	15 Participants n=5 Participants
Level of education Illiterate	1 Participants n=5 Participants
Level of education Incomplete primary school	21 Participants n=5 Participants
Level of education Complete primary school	61 Participants n=5 Participants
Level of education Complete secondary school	57 Participants n=5 Participants
Level of education Complete technical school	2 Participants n=5 Participants
Level of education Incomplete undergraduate school	9 Participants n=5 Participants
Level of education Complete undergraduate school	26 Participants n=5 Participants
Level of education Complete postgraduate school	2 Participants n=5 Participants
Body mass index	27.6 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants
Hypertension Yes	123 Participants n=5 Participants
Hypertension No	48 Participants n=5 Participants
Hypertension Missing	8 Participants n=5 Participants
Diabetes Yes	39 Participants n=5 Participants
Diabetes No	130 Participants n=5 Participants
Diabetes Did not know	2 Participants n=5 Participants
Diabetes Missing	8 Participants n=5 Participants
Heart failure Yes	86 Participants n=5 Participants
Heart failure No	81 Participants n=5 Participants
Heart failure Did not know	2 Participants n=5 Participants
Heart failure Missing	10 Participants n=5 Participants
Previous myocardial infarction Yes	42 Participants n=5 Participants
Previous myocardial infarction No	128 Participants n=5 Participants
Previous myocardial infarction Did not know	1 Participants n=5 Participants
Previous myocardial infarction Missing	8 Participants n=5 Participants
Previous stroke Yes	36 Participants n=5 Participants
Previous stroke No	92 Participants n=5 Participants
Previous stroke Did not know	1 Participants n=5 Participants
Previous stroke Missing	50 Participants n=5 Participants
Hypothyroidism Yes	20 Participants n=5 Participants
Hypothyroidism No	106 Participants n=5 Participants
Hypothyroidism Did not know	3 Participants n=5 Participants
Hypothyroidism Missing	50 Participants n=5 Participants
Chronic obstructive pulmonary disease Yes	11 Participants n=5 Participants
Chronic obstructive pulmonary disease No	117 Participants n=5 Participants
Chronic obstructive pulmonary disease Did not know	1 Participants n=5 Participants
Chronic obstructive pulmonary disease Missing	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Cardiac Arrhythmias Innovative 3-lead Wireless Water Resistant Holter System	107 Participants
Detection of Cardiac Arrhythmias Conventional Holter System	104 Participants

SECONDARY outcome

Timeframe: 24 hours

Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Atrial Fibrillation or Atrial Flutter Innovative 3-lead Wireless Water Resistant Holter System	23 Participants
Detection of Atrial Fibrillation or Atrial Flutter Conventional Holter System	22 Participants

SECONDARY outcome

Timeframe: 24 hours

Number of patients with supraventricular tachycardia (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter) detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Supraventricular Tachycardia Innovative 3-lead Wireless Water Resistant Holter System	71 Participants
Detection of Supraventricular Tachycardia Conventional Holter System	71 Participants

SECONDARY outcome

Timeframe: 24 hours

Number of patients with ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation) detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Ventricular Tachycardia Innovative 3-lead Wireless Water Resistant Holter System	26 Participants
Detection of Ventricular Tachycardia Conventional Holter System	23 Participants

SECONDARY outcome

Timeframe: 24 hours

Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation Innovative 3-lead Wireless Water Resistant Holter System	14 Participants
Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation Conventional Holter System	12 Participants

SECONDARY outcome

Timeframe: 24 hours

Number of patients with atrioventricular block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 2nd degree AV block Mobitz type I and II, AV block 2:1 or complete AV block) detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Atrioventricular Block Innovative 3-lead Wireless Water Resistant Holter System	5 Participants
Detection of Atrioventricular Block Conventional Holter System	4 Participants

SECONDARY outcome

Timeframe: 24 hours

Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Detection of Heart Beat Pauses Innovative 3-lead Wireless Water Resistant Holter System	7 Participants
Detection of Heart Beat Pauses Conventional Holter System	11 Participants

SECONDARY outcome

Timeframe: 24 hours

Duration of the Holter exam in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Duration of the Holter Exam Innovative 3-lead Wireless Water Resistant Holter System	21.79 hours Standard Deviation 1.40
Duration of the Holter Exam Conventional Holter System	21.74 hours Standard Deviation 1.95

SECONDARY outcome

Timeframe: 24 hours

Mean heart rate measured in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Mean Heart Rate Innovative 3-lead Wireless Water Resistant Holter System	69.73 beats per minute Standard Deviation 12.10
Mean Heart Rate Conventional Holter System	70.67 beats per minute Standard Deviation 12.24

SECONDARY outcome

Timeframe: 24 hours

Maximum heart rate measured in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Maximum Heart Rate Innovative 3-lead Wireless Water Resistant Holter System	113.59 beats per minute Standard Deviation 23.17
Maximum Heart Rate Conventional Holter System	116.30 beats per minute Standard Deviation 24.76

SECONDARY outcome

Timeframe: 24 hours

Minimum heart rate measured in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Minimum Heart Rate Innovative 3-lead Wireless Water Resistant Holter System	49.56 beats per minute Standard Deviation 9.83
Minimum Heart Rate Conventional Holter System	49.17 beats per minute Standard Deviation 8.87

SECONDARY outcome

Timeframe: 24 hours

Total number of atrial ectopic heart beats measured in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Atrial Ectopic Heart Beats Innovative 3-lead Wireless Water Resistant Holter System	717.09 atrial ectopic heart beats in 24 hr Standard Deviation 2323.94
Atrial Ectopic Heart Beats Conventional Holter System	723.46 atrial ectopic heart beats in 24 hr Standard Deviation 2223.27

SECONDARY outcome

Timeframe: 24 hours

Total number of ventricular ectopic heart beats measured in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Ventricular Ectopic Heart Beats Innovative 3-lead Wireless Water Resistant Holter System	1198.89 ventricular ectopic heart beats in 24 hr Standard Deviation 2651.33
Ventricular Ectopic Heart Beats Conventional Holter System	1187.85 ventricular ectopic heart beats in 24 hr Standard Deviation 2696.69

SECONDARY outcome

Timeframe: 24 hours

Total number of ventricular tachycardia episodes detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Episodes of Ventricular Tachycardia Innovative 3-lead Wireless Water Resistant Holter System	1.12 ventricular tachycardia episodes in 24hr Standard Deviation 6.29
Episodes of Ventricular Tachycardia Conventional Holter System	1.24 ventricular tachycardia episodes in 24hr Standard Deviation 7.86

SECONDARY outcome

Timeframe: 24 hours

Total number of supraventricular tachycardia episodes detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Episodes of Supraventricular Tachycardia Innovative 3-lead Wireless Water Resistant Holter System	5.71 supraventricular tachycardia episodes Standard Deviation 38.59
Episodes of Supraventricular Tachycardia Conventional Holter System	6.37 supraventricular tachycardia episodes Standard Deviation 41.10

SECONDARY outcome

Timeframe: 24 hours

Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors

Outcome measures

Outcome measures
Measure	Holter Device n=179 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Episodes of Heart Beat Pauses Innovative 3-lead Wireless Water Resistant Holter System	1.74 heart beat pauses in 24hr Standard Deviation 12.13
Episodes of Heart Beat Pauses Conventional Holter System	1.84 heart beat pauses in 24hr Standard Deviation 12.43

SECONDARY outcome

Timeframe: 24 hours

Population: Only 98 participants of the total of 179 responded the survey to assess the convenience of use of the Holter systems

Number of Participants Reporting the convenience of use of the Holter systems

Outcome measures

Outcome measures
Measure	Holter Device n=98 Participants In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device. An innovative 3-lead wireless water resistant Holter device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. A conventional device: The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Holter System Convenience of Use Innovative 3-lead Wireless Water Resistant Holter System	54 Participants
Holter System Convenience of Use Conventional Holter System	14 Participants
Holter System Convenience of Use No difference	30 Participants

Adverse Events

Holter Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trialist

Hospital Israelita Albert Einstein

Phone: 551121515915

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee It was agreed with the funding source that the trial results will be published in the Clinicaltrials.gov only.
Publication restrictions are in place

Restriction type: OTHER