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Hativ® Elektrokardiogramm-Überwachung bei Patienten mit Verdacht auf Arrhythmie (HELP-A)

30. September 2026 aktualisiert von: Young Jun Park, Wonju Severance Christian Hospital

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

588

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Dong-gu Jaebongro 42
      • Gwangju, Dong-gu Jaebongro 42, Südkorea, 61469
        • Rekrutierung
        • Chonnam National University Hospital
        • Kontakt:
    • Gangwon-do
      • Wŏnju, Gangwon-do, Südkorea, 26426
    • Hwaseong-si Keunjaebong-gil 7
      • Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, Südkorea, 18450
        • Rekrutierung
        • Hallym University Dongtan Sacred Heart Hospital
        • Kontakt:
    • Seongbuk-gu, 73 Goryeodae-ro
      • Seoul, Seongbuk-gu, 73 Goryeodae-ro, Südkorea, 02841
        • Rekrutierung
        • Korea University Anam Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

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.

Aktiver Komparator: 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.

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month
Zeitfenster: From randomization through the 1-month follow-up visit

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Positive symptom-rhythm correlation
Zeitfenster: By the 1-month follow-up visit

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
Zeitfenster: By the 1-month follow-up visit

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
Zeitfenster: By the 1-month follow-up visit

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
Zeitfenster: By the 1-month follow-up visit

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
Zeitfenster: Through 3 months after randomization

Rate and timing of arrhythmia-directed therapeutic interventions, including medication, catheter ablation, or cardiac device implantation.

Through 3 months after randomization
Overall satisfaction
Zeitfenster: 1-month follow-up visit

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
Zeitfenster: Baseline to 1 month

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
Zeitfenster: Through 3 months after randomization

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
Zeitfenster: Through 3 months after randomization

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sequential-monitoring participant questionnaire
Zeitfenster: 3-month follow-up

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Young Jun Park, MD, Wonju Severance Christian Hopsital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Februar 2024

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

30. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

31. Januar 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Februar 2024

Zuerst gepostet (Tatsächlich)

9. Februar 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • CR223024

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .