Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06043570
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-09-12
Brief Title:
Benfit of Remote Monitoring in Pacemaker
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Evaluation of Clinical and Economic Benefit Using Remote Monitoring in Patients With Pacemaker REMOTE-PM
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patients outcome
The incidence of atrial high rate episodes AHREsubclinical AF in patients with a pacemakerimplanted device is 30-70 but it may be lower in the general population Longer episodes of AHREsubclinical AF minimum of 5-6 min are associated with an increased risk of clinical AF ischemic stroke major adverse cardiovascular events and cardiovascular death13 Clinical AF will reportedly develop in 1 in 5-6 of patients within 25 years after diagnosing AHREsubclinical 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
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 patients outcome
The incidence of atrial high rate episodes AHREsubclinical AF in patients with a pacemakerimplanted device is 30-70 but it may be lower in the general population Longer episodes of AHREsubclinical AF minimum of 5-6 min are associated with an increased risk of clinical AF ischemic stroke major adverse cardiovascular events and cardiovascular death13 Clinical AF will reportedly develop in 1 in 5-6 of patients within 25 years after diagnosing AHREsubclinical 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 11 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 centers custom but no longer than 1 year between each visit Follow-up should be continued accordingly until two-years of device implant
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 11 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 centers custom but no longer than 1 year between each visit Follow-up should be continued accordingly until two-years of device implant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None