Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

NCT06250712 | Recruiting

• 1 other identifier: CR223024
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Arrhythmia

Keywords

Palpitation; Dizziness; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Positive symptom-rhythm correlation

  By the 1-month follow-up visit

• Negative-only symptom-rhythm correlation

  By the 1-month follow-up visit

• Both positive and negative episodes

  By the 1-month follow-up visit

• Clinically significant arrhythmia detected during assigned-device monitoring

  By the 1-month follow-up visit

• Arrhythmia-directed therapeutic intervention

  Through 3 months after randomization

Other Outcomes (1)

• Sequential-monitoring participant questionnaire

  3-month follow-up

Study Arms (2)

Memo Patch continuous ECG strategy

EXPERIMENTAL

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

Hativ handheld ECG strategy

ACTIVE COMPARATOR

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

Interventions

Memo Patch continuous ECG DEVICE

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.

Memo Patch continuous ECG strategy

Hativ handheld ECG DEVICE

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.

Hativ handheld ECG strategy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (4)

Chonnam National University Hospital

Gwangju, Dong-gu Jaebongro 42, 61469, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, 18450, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, Seongbuk-gu, 73 Goryeodae-ro, 02841, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 21697315 BACKGROUND

• 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.

  PMID: 37286259 BACKGROUND

• 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.

  PMID: 24672611 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Dizziness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Young Jun Park, MD

  Wonju Severance Christian Hopsital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Park, MD

CONTACT

82-2-920-5445; yjparkcardio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-group parallel randomized comparative-effectiveness trial. Optional sequential monitoring with the alternative device may occur only after ascertainment of the 1-month primary endpoint and is not part of the primary randomized comparison.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 9, 2024
• Study Start: February 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

KR (4)