Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 588
- 试验地点
- 8
- 主要终点
- Diagnostic yield
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Memo Patch continuous ECG (Device)
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.
干预措施: Hativ handheld ECG (Device)
结局指标
主要结局
Diagnostic yield
时间窗: 1 month
(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients
Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month
时间窗: 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.
次要结局
- Arrhythmia detection rate(3 month)
- Cost-effectiveness(3 month)
- Chagne of Quality of Life(Baseline, 3 month)
- User convenience(3 month)
- Healthcare resource utilization and costs(Through 3 months after randomization)
- 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)
- Safety Outcome(Through 3 months after randomization)
- Clinically significant arrhythmia detected during assigned-device monitoring(By the 1-month follow-up visit)
- Arrhythmia-directed therapeutic intervention(Through 3 months after randomization)
- Overall satisfaction(1-month follow-up visit)
- EQ-5D-5L(Baseline to 1 month)
研究者
Young Jun Park
Assistant Professor
Wonju Severance Christian Hospital