ArrhythmiaHELP-ANCT06250712
Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
A study testing Memo Patch continuous ECG and Hativ handheld ECG in people with Arrhythmia, run by Wonju Severance Christian Hospital at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Memo Patch continuous ECG and Hativ handheld ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 22 Feb 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Chonnam National University Hospital
Gwangju, Dong-gu Jaebongro 42, 61469
Ki hong Lee, MD, 82 01-9962-5830, drgood2@naver.com
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, 18450
Seong Woo Han Professor, MD, 82 01-2630-6489, hansw29@hallym.or.kr
- Recruiting
Korea University Anam Hospital
Seoul, Seongbuk-gu, 73 Goryeodae-ro, 02841
Young Jun Park, 82-2-920-5445, yjparkcardio@gmail.com
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Min-Soo Ahn, heartsaver@yonsei.ac.kr
About this study
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.
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- Memo Patch continuous ECG, Hativ handheld ECG
- Keywords
- Palpitation, Dizziness, Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memo Patch continuous ECGDevice
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.
Hativ handheld ECGDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Hativ handheld ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through the 1-month follow-up visit
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start22 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Jun Park, Wonju Severance Christian Hospital
- Investigators
- Young Jun Park, MD, Principal investigator, Wonju Severance Christian Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250712
- Sponsor's protocol ID
- CR223024
- Acronym
- HELP-A
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 21697315Turnbull 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.
PubMed 37286259Schreiber 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.
PubMed 24672611
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
- ClinicalTrials.gov ID
- NCT06250712
- Acronym / sponsor ID
- HELP-A / CR223024
- Conditions
- Arrhythmia
- Keywords
- Palpitation, Dizziness, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Memo Patch continuous ECG strategy | Experimental | Device: Memo Patch continuous ECGParticipants 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. |
| Hativ handheld ECG strategy | Active comparator | Device: Hativ handheld ECGParticipants use Hativ for 30 days and perform 10-second 6-lead ECG recordings at least twice daily and whenever symptoms occur. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memo Patch continuous ECGContinuous 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. | Device | Memo Patch continuous ECG strategy |
| Hativ handheld ECGHandheld 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. | Device | Hativ handheld ECG strategy |
Primary outcome
Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month
Time frame: 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.
9 secondary outcomes
Positive symptom-rhythm correlation
Time frame: By the 1-month follow-up visit
Negative-only symptom-rhythm correlation
Time frame: By the 1-month follow-up visit
Both positive and negative episodes
Time frame: By the 1-month follow-up visit
Clinically significant arrhythmia detected during assigned-device monitoring
Time frame: By the 1-month follow-up visit
Arrhythmia-directed therapeutic intervention
Time frame: Through 3 months after randomization
Overall satisfaction
Time frame: 1-month follow-up visit
EQ-5D-5L
Time frame: Baseline to 1 month
Healthcare resource utilization and costs
Time frame: Through 3 months after randomization
Number and Percentage of Participants With Device-Related Adverse Events or Serious Adverse Events
Time frame: Through 3 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 21697315Raviele 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.
- Background: PubMed 37286259Turnbull 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.
- Background: PubMed 24672611Schreiber 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Young Jun Park, MD principal investigator
Wonju Severance Christian Hopsital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memo Patch continuous ECG and Hativ handheld ECG in people with Arrhythmia, run by Wonju Severance Christian Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Park, MD (82-2-920-5445, yjparkcardio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month (time frame: From randomization through the 1-month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250712, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.