Pacemaker Implanted PatientsNCT06043570
Benfit of Remote Monitoring in Pacemaker
A study testing Remote Monitoring arm in people with Pacemaker Implanted Patients, run by Yonsei University at 1 site in South Korea.
Trial summary
Modern CIEDs are equipped with remote monitoring (RM) technology, which provides automatic transmissions of diagnostics and technical data from the implanted devices to the attending physician. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pacemaker Implanted Patients
- What is being tested?
- Remote Monitoring arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2023to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years
- Patients with permanent pacemaker with SenseAbility feature \& RM
- Ability to provide informed consent and to complete the study and required follow-up ④ Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
- Patient who refuse to use or expected to use less than 75% of remote monitoring system.
Who cannot join
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
- Thyroid gland dysfunction
- Pregnancy ④ Malignant tumor
- Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
- Life expectancy < 12 months ⑦ Patients unable or unwilling to cooperate in the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital Yonsei University
Seoul
Boyoung Joung, +82 02-2228-8460, thkimcardio@yuhs.ac
About this study
Official title: Evaluation of Clinical and Economic Benefit Using Remote Monitoring in Patients With Pacemaker (REMOTE-PM)
Modern CIEDs are equipped with remote monitoring (RM) technology, which provides automatic transmissions of diagnostics and technical data from the implanted devices to the attending physician. RM has been shown to be a safe alternative to the conventional in-hospital visits, especially for low-risk patients, such as pacemaker recipients. These regular office visits include examinations of device function and patient clinical status, and may prompt the reprogramming of the device or changes in medication regimens. The efficiency of this strategy is, however, questionable since, in the majority of scheduled visits, the device programming or drug regimen is left unchanged. To optimize the follow-up of device recipients, systems have been developed, which allow the automatic teletransmission of data stored in the devices' memories, including battery voltage, lead characteristics, and arrhythmias. The data sent by a home transmitter allow the remote surveillance of patients and eliminate unnecessary ambulatory visits. Clinical studies of these new systems have been conducted mostly in recipients of cardioverter defibrillators, and only a few studies of permanently paced patients have been published.
However, due to the absence of medical regulations and systems for remote monitoring in Korea, the government does not provide clear guidelines and the Korean HIRA (Health Insurance Review \& Assessment Service) is yet to set any reimbursement standards for home-transmitter and remote monitoring. As a result, most Korean physicians cannot practically use remote monitoring for CIED patients. Therefore, this project shall contribute to address the benefits of remote monitoring to the government and expediate the system to be set in the country.
Read more
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population. AF has enormous socioeconomic implications because it increases the risk of mortality and morbidity resulting from stroke, congestive heart failure, dementia and impaired quality of life. To prevent the AF-related complication, early detection of AF is very important. Despite the latest HRS Expert Consensus Statement which has set a class I recommendation for RM as useful tool for the early detection and quantification of AF, there are still few data on the clinical reactions triggered by the AHRE detected by RM of CIEDs and on their possible benefit on patient's outcome.
The incidence of atrial high rate episodes (AHRE)/subclinical AF in patients with a pacemaker/implanted device is 30-70%, but it may be lower in the general population. Longer episodes of AHRE/subclinical AF (minimum of 5-6 min) are associated with an increased risk of clinical AF, ischemic stroke, major adverse cardiovascular events, and cardiovascular death.13 Clinical AF will reportedly develop in 1 in 5-6 of patients within 2.5 years after diagnosing AHRE/subclinical AF.
The remote monitoring feature is available in all geographies while it is yet to be reimbursed in South Korea. To be reimbursed by the NHIS of Korea, the data supporting the benefit of RM is necessary. By comparing clinical and economic benefits of remote monitoring, we might be able to set a guideline on the usage of remote monitoring in pacemaker patients.
Read the detailed description
- Study Objective Primary study objective The primary objective of this non-inferiority, prospective trial in Korean population is to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including (i) death, (ii) hospitalization for complications related to the pacing system, and (iii) hospitalization for an adverse cardiovascular event, is not higher in the remote follow-up (active) than in the standard care (control) group.
- Secondary objectives The secondary objectives of the trial are to address the economic benefits of remote monitoring to the government and expediate the system to be set in the country. Through this trial, we expect to set reimbursement policy in corporation with KHRS (Korean Heart Rhythm Society) including home transmitter. In addition, since Korea has one of the highest usage rate of smartphones even in elderly groups compared to Europe or North America, we are to suggest a set of guidelines for patient care and follow up schedules for remote monitoring patients according to Korean culture and circumstances.
- Study Design We propose to prospectively recruit 900 patients with pacemaker with SenseAbility feature implantation in multiple sites in Korea.
- Eligible patients should be enrolled in remote monitoring system 0 to 45 days after successful device implantation and then randomly assigned in a 1:1 ratio to the RM or conventional follow-up group.
- In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.
- In the conventional follow-up arm, the patients should be seen at the clinic according to each center's custom but no longer than 1 year between each visit. Follow-up should be continued accordingly until two-years of device implant.
- Conditions
- Pacemaker Implanted Patients
- Being tested
- Remote Monitoring arm
- Keywords
- Pacemaker, remote monitoring, benefit, economic, financial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring armDevice
Patients will be follow-up using remote monitoring. In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.
| Study group | Role | What they receive |
|---|---|---|
| Remote Monitoring follow up | Experimental | Not described Receives: Device: Remote Monitoring arm |
| Conventional Follow up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse event (MAE)
major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
Secondary outcomes (7)
Economic benefit by remote mononitoring
economic benefit of each treatment
Measured: 24 month
all-cause death
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
hospitalizations for device-related events
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
cardiovascular adverse events
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
AHRE/subclinical AF
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
clinical AF
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
time to change of management including OAC
Measured: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Jan 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker Implanted PatientsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043570
- Sponsor's protocol ID
- 1-2022-0049
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Economic Benefit Using Remote Monitoring in Patients With Pacemaker (REMOTE-PM)
- ClinicalTrials.gov ID
- NCT06043570
- Acronym / sponsor ID
- 1-2022-0049
- Conditions
- Pacemaker Implanted Patients
- Keywords
- Pacemaker, remote monitoring, benefit, economic, financial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (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.
Modern CIEDs are equipped with remote monitoring (RM) technology, which provides automatic transmissions of diagnostics and technical data from the implanted devices to the attending physician. RM has been shown to be a safe alternative to the conventional in-hospital visits, especially for low-risk patients, such as pacemaker recipients. These regular office visits include examinations of device function and patient clinical status, and may prompt the reprogramming of the device or changes in medication regimens. The efficiency of this strategy is, however, questionable since, in the majority of scheduled visits, the device programming or drug regimen is left unchanged. To optimize the follow-up of device recipients, systems have been developed, which allow the automatic teletransmission of data stored in the devices' memories, including battery voltage, lead characteristics, and arrhythmias. The data sent by a home transmitter allow the remote surveillance of patients and eliminate unnecessary ambulatory visits. Clinical studies of these new systems have been conducted mostly in recipients of cardioverter defibrillators, and only a few studies of permanently paced patients have been published.
However, due to the absence of medical regulations and systems for remote monitoring in Korea, the government does not provide clear guidelines and the Korean HIRA (Health Insurance Review \& Assessment Service) is yet to set any reimbursement standards for home-transmitter and remote monitoring. As a result, most Korean physicians cannot practically use remote monitoring for CIED patients. Therefore, this project shall contribute to address the benefits of remote monitoring to the government and expediate the system to be set in the country.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population. AF has enormous socioeconomic implications because it increases the risk of mortality and morbidity resulting from stroke, congestive heart failure, dementia and impaired quality of life. To prevent the AF-related complication, early detection of AF is very important. Despite the latest HRS Expert Consensus Statement which has set a class I recommendation for RM as useful tool for the early detection and quantification of AF, there are still few data on the clinical reactions triggered by the AHRE detected by RM of CIEDs and on their possible benefit on patient's outcome.
The incidence of atrial high rate episodes (AHRE)/subclinical AF in patients with a pacemaker/implanted device is 30-70%, but it may be lower in the general population. Longer episodes of AHRE/subclinical AF (minimum of 5-6 min) are associated with an increased risk of clinical AF, ischemic stroke, major adverse cardiovascular events, and cardiovascular death.13 Clinical AF will reportedly develop in 1 in 5-6 of patients within 2.5 years after diagnosing AHRE/subclinical AF.
The remote monitoring feature is available in all geographies while it is yet to be reimbursed in South Korea. To be reimbursed by the NHIS of Korea, the data supporting the benefit of RM is necessary. By comparing clinical and economic benefits of remote monitoring, we might be able to set a guideline on the usage of remote monitoring in pacemaker patients.
Detailed description
- Study Objective Primary study objective The primary objective of this non-inferiority, prospective trial in Korean population is to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including (i) death, (ii) hospitalization for complications related to the pacing system, and (iii) hospitalization for an adverse cardiovascular event, is not higher in the remote follow-up (active) than in the standard care (control) group.
- Secondary objectives The secondary objectives of the trial are to address the economic benefits of remote monitoring to the government and expediate the system to be set in the country. Through this trial, we expect to set reimbursement policy in corporation with KHRS (Korean Heart Rhythm Society) including home transmitter. In addition, since Korea has one of the highest usage rate of smartphones even in elderly groups compared to Europe or North America, we are to suggest a set of guidelines for patient care and follow up schedules for remote monitoring patients according to Korean culture and circumstances.
- Study Design We propose to prospectively recruit 900 patients with pacemaker with SenseAbility feature implantation in multiple sites in Korea.
- Eligible patients should be enrolled in remote monitoring system 0 to 45 days after successful device implantation and then randomly assigned in a 1:1 ratio to the RM or conventional follow-up group.
- In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.
- In the conventional follow-up arm, the patients should be seen at the clinic according to each center's custom but no longer than 1 year between each visit. Follow-up should be continued accordingly until two-years of device implant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Monitoring follow up | Experimental | Device: Remote Monitoring arm |
| Conventional Follow up | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-80 years
Key exclusion criteria (5 listed)
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
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 |
|---|---|---|
| Remote Monitoring armPatients will be follow-up using remote monitoring. In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification. | Device | Remote Monitoring follow up |
Primary outcome
major adverse event (MAE)
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events
7 secondary outcomes
Economic benefit by remote mononitoring
Time frame: 24 month
all-cause death
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
hospitalizations for device-related events
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
cardiovascular adverse events
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
AHRE/subclinical AF
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
clinical AF
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
time to change of management including OAC
Time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring arm in people with Pacemaker Implanted Patients, run by Yonsei University at 1 site 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 4 inclusion and 5 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Boyoung Joung (+82 02-2228-8460, thkimcardio@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse event (MAE) (time frame: Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month). 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 21 Sep 2023.