Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia (HELP-A)

HELP-A is a prospective, randomized, open-label, multicenter comparative-effectiveness trial comparing two ambulatory electrocardiographic monitoring strategies in adults with palpitations or dizziness and a nondiagnostic 12-lead ECG. A total of 588 participants are randomized 1:1 to 30-day intermittent handheld 6-lead ECG monitoring (Hativ) or up to 7 days of continuous single-lead patch ECG monitoring (Memo Patch). The primary endpoint is clinically informative symptom-rhythm correlation established with the initially assigned device by the 1-month follow-up visit. Participants without a symptom-rhythm correlation who remain symptomatic may undergo optional sequential monitoring with the alternative device after primary endpoint ascertainment. Clinical outcomes, arrhythmia-directed interventions, healthcare resource utilization, costs, and adverse events are assessed through 3 months.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Memo Patch continuous ECG; Device: Hativ handheld ECG

Detailed Description

HELP-A is an investigator-initiated, prospective, randomized, open-label, multicenter comparative-effectiveness trial conducted at four tertiary hospitals in South Korea. The study evaluates two ambulatory ECG monitoring strategies in adults with palpitations or dizziness that are not explained by a presenting 12-lead ECG and for whom additional ambulatory rhythm monitoring is clinically indicated.

Participants are randomized in a 1:1 ratio, stratified by participating center, to one of two monitoring strategies. Participants assigned to Hativ use a handheld ECG device that provides 10-second 6-lead ECG recordings. They are instructed to record at least twice daily and whenever symptoms occur for 30 days. Participants assigned to Memo Patch undergo continuous single-lead ECG monitoring for up to 7 consecutive days and report symptom onset using a mobile messaging chatbot or paper diary. For each reported symptom, a 20-minute ECG segment from 10 minutes before to 10 minutes after the reported onset is available for review.

The primary endpoint is clinically informative symptom-rhythm correlation established with the initially assigned device by the 1-month follow-up visit. A positive correlation requires an interpretable ECG obtained during a participant-confirmed typical symptomatic episode with a rhythm finding judged to be temporally and clinically concordant with that episode. A negative-only correlation requires at least one qualifying symptomatic episode with an interpretable ECG showing no concordant rhythm finding and no positive correlation by the 1-month visit. Both positive and negative-only correlations count as primary-endpoint success.

Because the assigned monitoring durations differ, a prespecified key secondary analysis re-ascertains the primary endpoint using only data from the first 7 days after randomization, representing the common planned 7-day monitoring window. Clinically significant arrhythmia is evaluated separately from symptom-rhythm correlation and is adjudicated centrally using prespecified device-specific operational definitions.

After completion of the 1-month primary endpoint assessment, participants with persistent symptoms and no clinically informative symptom-rhythm correlation may undergo optional sequential monitoring with the alternative device if further monitoring remains clinically appropriate and the participant agrees. Data obtained during sequential monitoring do not contribute to the primary randomized comparison and are analyzed as exploratory outcomes.

All randomized participants are followed through 3 months. Follow-up includes arrhythmia-directed therapeutic interventions, clinical events, healthcare resource utilization and costs, adverse events, and selected patient-reported outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 588
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Park, MD; Phone Number: 82-2-920-5445; Email: yjparkcardio@gmail.com

Study Locations

• South Korea
  • Dong-gu Jaebongro 42
    • Gwangju, Dong-gu Jaebongro 42, South Korea, 61469
      • Recruiting
      • Chonnam National University Hospital
      • Contact: Ki hong Lee, MD; Phone Number: 82 01-9962-5830; Email: drgood2@naver.com
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Recruiting
      • Wonju Severance Christian Hospital
      • Contact: Min-Soo Ahn; Email: heartsaver@yonsei.ac.kr
  • Hwaseong-si Keunjaebong-gil 7
    • Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, South Korea, 18450
      • Recruiting
      • Hallym University Dongtan Sacred Heart Hospital
      • Contact: Seong Woo Han Professor, MD; Phone Number: 82 01-2630-6489; Email: hansw29@hallym.or.kr
  • Seongbuk-gu, 73 Goryeodae-ro
    • Seoul, Seongbuk-gu, 73 Goryeodae-ro, South Korea, 02841
      • Recruiting
      • Korea University Anam Hospital
      • Contact: Young Jun Park; Phone Number: 82-2-920-5445; Email: yjparkcardio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 19 years or older.
• Palpitations or dizziness not explained by the presenting 12-lead ECG.
• A clinical indication for additional ambulatory ECG monitoring.
• Ownership of and ability to use a compatible smartphone.
• Ability to provide written informed consent and comply with study procedures

Exclusion Criteria:

• Physical disability or another condition that prevents appropriate use of the handheld ECG device.
• Presence of a cardiac implantable electronic device or ventricular assist device.
• Inability to read or understand the informed consent document.
• Any other condition that, in the investigator's judgment, makes participation in the study inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memo Patch continuous ECG strategy; Participants undergo continuous single-lead ECG monitoring with Memo Patch for up to 7 consecutive days and report symptom onset using a mobile messaging chatbot or paper diary.	Device: Memo Patch continuous ECG; Continuous single-lead ECG monitoring for up to 7 consecutive days. Participants report the onset of symptoms using a mobile messaging chatbot or paper diary. For each reported symptomatic episode, a 20-minute ECG segment extending from 10 minutes before to 10 minutes after the reported onset is available for review.
Active Comparator: Hativ handheld ECG strategy; Participants use Hativ for 30 days and perform 10-second 6-lead ECG recordings at least twice daily and whenever symptoms occur.	Device: Hativ handheld ECG; Handheld ECG monitoring using 10-second 6-lead recordings obtained at least twice daily and additionally whenever symptoms occur for 30 days. Recordings are transmitted through the companion smartphone application to a secure study server.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month	Proportion of randomized participants with at least one participant-confirmed typical symptomatic episode documented with an interpretable ECG using the initially assigned device by the 1-month follow-up visit and before optional sequential monitoring. Primary-endpoint success comprises either a positive symptom-rhythm correlation or a negative-only symptom-rhythm correlation. A positive correlation is a qualifying symptomatic episode with an interpretable ECG showing a rhythm finding judged by central adjudication to be temporally and clinically concordant with that episode. A negative-only correlation requires at least one qualifying symptomatic episode with an interpretable ECG showing no concordant rhythm finding and no positive correlation by the 1-month visit.	From randomization through the 1-month follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive symptom-rhythm correlation	Proportion of participants with at least one qualifying participant-confirmed typical symptomatic episode documented with an interpretable ECG showing a rhythm finding judged by central adjudication to be temporally and clinically concordant with that episode.	By the 1-month follow-up visit
Negative-only symptom-rhythm correlation	Proportion of participants with at least one qualifying participant-confirmed typical symptomatic episode documented with an interpretable ECG showing no temporally and clinically concordant rhythm finding and with no positive correlation by the 1-month follow-up visit.	By the 1-month follow-up visit
Both positive and negative episodes	Proportion of participants with at least one qualifying positive symptom-rhythm correlation and at least one qualifying negative symptom-rhythm correlation. This measure is descriptive.	By the 1-month follow-up visit
Clinically significant arrhythmia detected during assigned-device monitoring	Proportion of participants with at least one centrally adjudicated clinically significant arrhythmia detected during initially assigned-device monitoring, irrespective of symptom association. Clinically significant arrhythmias are classified using prespecified device-specific operational definitions. Findings are additionally classified as symptom-associated or not temporally associated with a qualifying typical symptomatic episode.	By the 1-month follow-up visit
Arrhythmia-directed therapeutic intervention	Rate and timing of arrhythmia-directed therapeutic interventions, including medication, catheter ablation, or cardiac device implantation.	Through 3 months after randomization
Overall satisfaction	Overall satisfaction with the initially assigned device is assessed using the Study-Specific Overall Device Satisfaction Rating, a single-item, five-point ordinal scale in the 1-month participant questionnaire. Responses are scored as 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. The minimum possible score is 1 and the maximum is 5, with higher scores indicating greater satisfaction, a more favorable outcome. The item is assessed separately from device-specific usability questions and willingness to recommend the device.	1-month follow-up visit
EQ-5D-5L	Change in the EQ-5D-5L index score from enrollment to the 1-month follow-up visit.	Baseline to 1 month
Healthcare resource utilization and costs	Arrhythmia-related healthcare resource use through 3 months, including additional diagnostic tests, arrhythmia-related medications, emergency department visits, and hospitalizations. Costs are derived from institutional billing records at participating centers and expressed in Korean won. The base-case analysis excludes acquisition cost of the study devices because the devices were supplied in kind.	Through 3 months after randomization
Number and Percentage of Participants With Device-Related Adverse Events or Serious Adverse Events	Number and percentage of participants who experience at least one device-related adverse event or at least one serious adverse event through 3 months after randomization. Expected device-related adverse events include skin irritation or contact dermatitis associated with the adhesive patch and discomfort associated with device use. Serious adverse events are included regardless of their relationship to the study device. Each participant is counted once for this outcome, irrespective of the number of qualifying events experienced	Through 3 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential-monitoring participant questionnaire	Among participants who undergo optional sequential monitoring with both study devices, paired evaluations are collected using the Study-Specific Three-Month Head-to-Head Device Evaluation Questionnaire. Device usability is assessed separately for each device using eight items. Each item is scored from 1 (very difficult) to 5 (very easy), with 2 = difficult, 3 = neither difficult nor easy, and 4 = easy. The minimum possible score for each item is 1 and the maximum is 5; higher scores indicate better perceived usability. "Not applicable" responses are recorded separately and are not assigned a numerical score. Usability items are reported individually rather than combined into a total score. Overall satisfaction with each device is assessed using a single five-point ordinal item, scored from 1 (very dissatisfied) to 5 (very satisfied), with 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, and 4 = satisfied. The minimum possible score is 1 and the maximum is 5; higher scores i	3-month follow-up

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Investigators: Principal Investigator: Young Jun Park, MD, Wonju Severance Christian Hopsital

Publications and helpful links

General Publications

• Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973.
• Raviele A, Giada F, Bergfeldt L, Blanc JJ, Blomstrom-Lundqvist C, Mont L, Morgan JM, Raatikainen MJ, Steinbeck G, Viskin S, Kirchhof P, Braunschweig F, Borggrefe M, Hocini M, Della Bella P, Shah DC; European Heart Rhythm Association. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011 Jul;13(7):920-34. doi: 10.1093/europace/eur130. No abstract available.
• Turnbull S, Garikapati K, Bennett RG, Campbell TG, Kotake Y, Mahajan R, Marschner S, Byth K, Chow CK, Kumar S. Utility of a Handheld, Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias. J Am Coll Cardiol. 2023 Jun 13;81(23):2292-2294. doi: 10.1016/j.jacc.2023.03.428. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): October 5, 2026
• Last Update Submitted That Met QC Criteria: September 30, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Arrhythmia; Dizziness; Palpitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arrhythmias, Cardiac; Dizziness
• Other Study ID Numbers: CR223024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data underlying the primary publication, together with a data dictionary, will be available from the corresponding investigator on reasonable request after completion of the study and publication of the primary results, subject to ethics approval and execution of an appropriate data-use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No