Atrial Fibrillation (AF)PREEMPT-AFNCT06751459
Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy
A study testing MEMO Patch 2 - 14-day Monitoring, MEMO Patch 2 - 1-day Monitoring and MEMO Link in people with Atrial Fibrillation (AF), run by HUINNO Co., Ltd at 7 sites in South Korea.
Trial summary
Background: Atrial fibrillation (AF) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. Catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- MEMO Patch 2 - 14-day Monitoring, MEMO Patch 2 - 1-day Monitoring and MEMO Link
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 6 Jan 2025to 1 Mar 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
- 1. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.
- 2. Individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition.
- 3. Individuals who are scheduled to undergo catheter ablation for atrial fibrillation within three months from the date of informed consent acquisition.
Who cannot join
- 1. Individuals with a history of catheter ablation prior to obtaining informed consent.
- 2. Individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders.
- 3. Individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices.
- 4. Individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial.
- 5. Individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision.
- 6. Pregnant or breastfeeding women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
South Korea7 sites
Dong-A University Hospital
Busan, 49201
Jongseong Park, +82-51-240-5040, thinkmed@naver.com
Busan National University Hospital
Busan, 49241
Jinhee An, +82-51-240-7794, reinee81@naver.com
Seoul National University Bundang Hospital
Seongnam, 13620
Ilyoung Oh, +82-10-8620-0510, spy510@snu.ac.kr
Korea University Anam Hospital
Seoul, 02855
Jongil Choi, +82-10-2122-5476, jongilchoi@korea.ac.kr
Asan Medical Center
Seoul, 05505
Gibyung Nam, +82-10-3127-5681, gbnam@amc.seoul.kr
Ewha Womans University Seoul Hospital
Seoul, 07804
Donghyuk Kim, +82-10-2724-7740, tomas9912@naver.com
Korea University Guro Hospital
Seoul, 08308
Seungyoung Ro, +82-10-3612-6876, rsy008@gmail.com
About this study
Official title: Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial
Background:
Atrial fibrillation (AF) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. Catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. Conventional intermittent ECG monitoring lacks sufficient sensitivity to detect asymptomatic AF recurrence effectively.
Read more
Objective:
To compare the recurrence rates of atrial tachyarrhythmias between a 1-day monitoring group and a 14-day monitoring group using MEMO Patch 2 after catheter ablation in AF patients. The study also evaluates the effectiveness and safety of early recurrence detection via remote monitoring.
Study Population:
Patients diagnosed with AF and treated with catheter ablation.
Intervention:
Participants will undergo three sessions of remote ECG monitoring using MEMO Patch 2 and MEMO Link (first session only), spanning approximately one year after catheter ablation.
Hypothesis:
Long-term monitoring with MEMO Patch 2 will be more effective than 1-day monitoring in detecting the recurrence of atrial tachyarrhythmias (including AF, atrial flutter, and atrial tachycardia) following catheter ablation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- MEMO Patch 2 - 14-day Monitoring, MEMO Patch 2 - 1-day Monitoring, MEMO Link
- Keywords
- Atrial fibrillation, circulatory system, EKG, remote monitoring, gateway, MEMO-Patch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO Patch 2 - 14-day MonitoringDevice
A wearable ECG monitoring device used for continuous 14-day monitoring to detect atrial arrhythmias during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to assess early recurrence of atrial arrhythmias.
MEMO Patch 2 - 1-day MonitoringDevice
A wearable ECG monitoring device used for 1-day monitoring during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to detect early recurrence of atrial arrhythmias.
MEMO LinkDevice
A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation:
1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be performed for 14 days using both the MEMO Patch 2 and MEMO Link.
2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be performed for 14 days using only the MEMO Patch 2.
3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will again be performed for 14 days using only the MEMO Patch 2. Receives: Device: MEMO Patch 2 - 1-day Monitoring; Device: MEMO Link |
| Active Comparator Group | Active comparator | Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation:
1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be conducted for 14 days using both the MEMO Patch 2 and MEMO Link.
2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be conducted for 1 day using only the MEMO Patch 2.
3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will be conducted for 14 days using only the MEMO Patch 2. Receives: Device: MEMO Patch 2 - 14-day Monitoring; Device: MEMO Link |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation
The proportion of participants with atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or more) detected during ECG monitoring at 3 months after catheter ablation using the MEMO Patch 2. The primary measure focuses on comparing the detection rate between the 14-day monitoring group and the 1-day monitoring group.
Measured: 3 months post-ablation
Secondary outcomes (9)
Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias
Identification of clinical risk factors associated with early recurrence (within 3 months) and late recurrence (beyond 3 months) of atrial tachyarrhythmias following catheter ablation, using data collected through MEMO Patch 2 monitoring.
Measured: 12 months post-ablation
Rate of Medical Interventions Following Catheter Ablation
Proportion of participants requiring additional medical interventions such as anti-arrhythmic drug cessation, repeat ablation procedures, or unplanned clinical visits post-ablation.
Measured: 12 months post-ablation
Recurrence Rate of Atrial Tachyarrhythmias at 12 Months
Proportion of participants experiencing atrial tachyarrhythmias (lasting 30 seconds or more) detected by MEMO Patch 2 within 12 months after catheter ablation.
Measured: 12 months post-ablation
Early Recurrence Rate of Atrial Tachyarrhythmias
Proportion of participants with atrial tachyarrhythmias detected within 3 months post-ablation using MEMO Patch 2.
Measured: 3 months post-ablation
Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2
Proportion of participants with non-atrial tachyarrhythmias, such as ventricular premature contractions or supraventricular tachycardia, detected during MEMO Patch 2 monitoring.
Measured: 12 months post-ablation
Time to First Recurrence of Atrial Tachyarrhythmias
The time interval from catheter ablation to the first detection of atrial tachyarrhythmias lasting 30 seconds or more during MEMO Patch 2 monitoring.
Measured: 12 months post-ablation
ECG Signal Transmission Success Rate Using MEMO Link
Percentage of successfully transmitted ECG signals during the monitoring period using the MEMO Link device.
Measured: During all monitoring periods (up to 12 months post-ablation)
Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports
Proportion of participants with atrial tachyarrhythmias detected using daily ECG monitoring reports during the first monitoring phase (up to 30 days post-ablation).
Measured: 30 days post-ablation (first monitoring phase)
Device-Related Adverse Events
Rate of adverse events potentially related to the use of MEMO Patch 2 or MEMO Link during the study period, assessed through investigator reports.
Measured: During all monitoring periods (up to 12 months post-ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 Jan 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUINNO Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751459
- Sponsor's protocol ID
- PREEMPT-AF
- Acronym
- PREEMPT-AF
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including basic demographic data and primary research outcome data, will be shared. These data will specifically pertain to research conducted on remote monitoring and atrial fibrillation. The shared data will not contain any personal identifiers to ensure participant When the data are made available, a direct link to the external repository hosting the IPD will be provided in the References module of the Protocol Section on ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial
- ClinicalTrials.gov ID
- NCT06751459
- Acronym / sponsor ID
- PREEMPT-AF / PREEMPT-AF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, circulatory system, EKG, remote monitoring, gateway, MEMO-Patch
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- HUINNO Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Dec 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.
Background:
Atrial fibrillation (AF) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. Catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. Conventional intermittent ECG monitoring lacks sufficient sensitivity to detect asymptomatic AF recurrence effectively.
Objective:
To compare the recurrence rates of atrial tachyarrhythmias between a 1-day monitoring group and a 14-day monitoring group using MEMO Patch 2 after catheter ablation in AF patients. The study also evaluates the effectiveness and safety of early recurrence detection via remote monitoring.
Study Population:
Patients diagnosed with AF and treated with catheter ablation.
Intervention:
Participants will undergo three sessions of remote ECG monitoring using MEMO Patch 2 and MEMO Link (first session only), spanning approximately one year after catheter ablation.
Hypothesis:
Long-term monitoring with MEMO Patch 2 will be more effective than 1-day monitoring in detecting the recurrence of atrial tachyarrhythmias (including AF, atrial flutter, and atrial tachycardia) following catheter ablation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: MEMO Patch 2 - 1-day Monitoring, Device: MEMO LinkParticipants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation: 1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be performed for 14 days using both the MEMO Patch 2 and MEMO Link. 2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be performed for 14 days using only the MEMO Patch 2. 3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will again be performed for 14 days using only the MEMO Patch 2. |
| Active Comparator Group | Active comparator | Device: MEMO Patch 2 - 14-day Monitoring, Device: MEMO LinkParticipants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation: 1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be conducted for 14 days using both the MEMO Patch 2 and MEMO Link. 2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be conducted for 1 day using only the MEMO Patch 2. 3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will be conducted for 14 days using only the MEMO Patch 2. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.
- 2. Individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition.
- 3. Individuals who are scheduled to undergo catheter ablation for atrial fibrillation within three months from the date of informed consent acquisition.
Key exclusion criteria (6 listed)
- 1. Individuals with a history of catheter ablation prior to obtaining informed consent.
- 2. Individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders.
- 3. Individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices.
- 4. Individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial.
- 5. Individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision.
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 2 - 14-day MonitoringA wearable ECG monitoring device used for continuous 14-day monitoring to detect atrial arrhythmias during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to assess early recurrence of atrial arrhythmias. | Device | Active Comparator Group |
| MEMO Patch 2 - 1-day MonitoringA wearable ECG monitoring device used for 1-day monitoring during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to detect early recurrence of atrial arrhythmias. | Device | Experimental Group |
| MEMO LinkA supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session. | Device | Active Comparator Group, Experimental Group |
Primary outcome
Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation
Time frame: 3 months post-ablation
The proportion of participants with atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or more) detected during ECG monitoring at 3 months after catheter ablation using the MEMO Patch 2. The primary measure focuses on comparing the detection rate between the 14-day monitoring group and the 1-day monitoring group.
9 secondary outcomes
Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias
Time frame: 12 months post-ablation
Rate of Medical Interventions Following Catheter Ablation
Time frame: 12 months post-ablation
Recurrence Rate of Atrial Tachyarrhythmias at 12 Months
Time frame: 12 months post-ablation
Early Recurrence Rate of Atrial Tachyarrhythmias
Time frame: 3 months post-ablation
Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2
Time frame: 12 months post-ablation
Time to First Recurrence of Atrial Tachyarrhythmias
Time frame: 12 months post-ablation
ECG Signal Transmission Success Rate Using MEMO Link
Time frame: During all monitoring periods (up to 12 months post-ablation)
Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports
Time frame: 30 days post-ablation (first monitoring phase)
Device-Related Adverse Events
Time frame: During all monitoring periods (up to 12 months post-ablation)
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 31 Dec 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including basic demographic data and primary research outcome data, will be shared. These data will specifically pertain to research conducted on remote monitoring and atrial fibrillation. The shared data will not contain any personal identifiers to ensure participant When the data are made available, a direct link to the external repository hosting the IPD will be provided in the References module of the Protocol Section on ClinicalTrials.gov.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
7 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 2 - 14-day Monitoring, MEMO Patch 2 - 1-day Monitoring and MEMO Link in people with Atrial Fibrillation (AF), run by HUINNO Co., Ltd at 7 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Jong-il Choi (+821021225476, stabler92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation (time frame: 3 months post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.