Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03877913
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2019-03-14
Brief Title:
Daily ECG Versus 7-day Holter ECG After Atrial Fibrillation Ablation
Sponsor:
Centre of Postgraduate Medical Education
Organization:
Centre of Postgraduate Medical Education
Study Overview
Official Title:
Daily ECG Transmission Versus Serial 7-day Holter ECG for Assessment of Efficacy of Ablation for Atrial Fibrillation - the AGNES-ECG Study
Status:
COMPLETED
Status Verified Date:
2023-03
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:
AGNES-ECG
Brief Summary:
Introduction
The optimal method for the assessment of efficacy of ablation for atrial fibrillation AF has not yet been established The symptom-based evaluation is not accurate because many AF episodes are asymptomatic It has been well documented that the more frequent andor longer ECG recording the more the AF recurrences are detected However such devices for long-term ECG monitoring as implantable loop recorders are expensive whereas external ECG monitoring is not well tolerated over a period longer than one month The most frequently used approach is periodic 1-7 day Holter ECG monitoring usually performed 3 6 and 12 months after the procedure and additional standard ECG recordings when symptoms occur Using this method asymptomatic AF episodes occurring between Holter ECG recordings are missed
Recently several types of external ECG recorders have been introduced enabling good quality frequent ECG recordings and transmission via mobile phones Only a few studies documented the usefulness of this method in detecting silent AF in a high-risk population however the value of short but frequent ECG recordings after AF ablation has not yet been established In these studies short ECG recordings performer once or twice daily detected the highest number of AF episodes
In summary data on the optimal type of ECG monitoring after AF ablation are scarce It seems that frequent short ECG recordings have more diagnostic yield than 24-hour ECG monitoring even when performed monthly or standard care with recording ECG only when symptoms suggesting AF occur However the optimal mode of monitoring is not known Such questions as whether once-a-day ECG transmission is enough and whether longer ie 7-day Holter ECG may be as valuable as daily ECG transmissions remain unanswered
Aim to compare daily ECG transmissions with repeated 7-day Holter ECG in detecting AF episodes following AF ablation
Hypothesis daily ECG recordings have significantly higher yield in AF detection than repeated 7-day Holter ECG
Methods
The study group will consists of 50 consecutive patients undergoing AF ablation in the investigators center Only patient capable of maintain ISTEL recorder and transmitting ECG will be enrolled in the study 1-2 day after catheter ablation for AF The follow-up will last 12 months The AF detection will be performed using two recording methods in each patient The number of 50 patients has been chosen based on the assumption that Holter ECG will detect AF recurrence in 15 of patients and daily transmission will detect AF recurrence in 38 patients alfa error 005 and beta error 02
Daily ECG recordings and transmissions will be performed using the HR-2000 recorder ISTEL Poland This device enables recording of 30 seconds of 6-channel ECG I II III aVR aVL aVF from 4 metal electrodes build in the recorder In order to record ECG the device is activated by a patient and attached to the thorax at the area of sternum The duration of recording may vary from 30 seconds to 3 minutes however only 30-second recordings will be used in the present study After recording ECG will be transmitted using Bluetooth to patients smartphone and then transmitted to the central station where they will be stored and analyzed Analysis will be performed on a daily basis by an experienced ECG technician not directly involved in patients recruitment and treatment The results of all recordings will be available for study team after 3 6 and 12 months after ablation at the time when concurrent Holter ECG recordings will be analyzed Only in case of serious life-threatening arrhythmias non-sustained or sustained ventricular tachycardia or pauses 6 seconds the study team will be informed immediately by a technician about the results of 30-second ECG recording in order to undertake proper action Specifically asymptomatic episodes of AF will not be unblinded to the study team in order not to interfere with medication and to allow continuing follow-up till next Holter ECG monitoring
The second method of ECG recording will be 7-day Holter ECG DMS 300-4A recorders DM Software NV USA performed 3 6 and 12 months after ablation
The patients will be allowed to record additional ECG when symptoms suggesting AF occur This may be performed by ISTEL recorder or standard 12-lead ECG if available
At each time-point 3 6 and 12 months the study team will analyze all recorded ECGs and 7-day Holter ECG and make appropriate therapeutic decisions
Anticipated results
Daily ECG recordings will detect first AF episode faster than standard Holter monitoring
ISTEL recorder will identify more patients with AF recurrence than standard Holter monitoring
ISTEL recorder will identify more patients with asymptomatic AF recurrence than standard Holter monitoring
Definitions
AF episode - episode lasting 30 seconds Study period August 2018 - August 2020
The optimal method for the assessment of efficacy of ablation for atrial fibrillation AF has not yet been established The symptom-based evaluation is not accurate because many AF episodes are asymptomatic It has been well documented that the more frequent andor longer ECG recording the more the AF recurrences are detected However such devices for long-term ECG monitoring as implantable loop recorders are expensive whereas external ECG monitoring is not well tolerated over a period longer than one month The most frequently used approach is periodic 1-7 day Holter ECG monitoring usually performed 3 6 and 12 months after the procedure and additional standard ECG recordings when symptoms occur Using this method asymptomatic AF episodes occurring between Holter ECG recordings are missed
Recently several types of external ECG recorders have been introduced enabling good quality frequent ECG recordings and transmission via mobile phones Only a few studies documented the usefulness of this method in detecting silent AF in a high-risk population however the value of short but frequent ECG recordings after AF ablation has not yet been established In these studies short ECG recordings performer once or twice daily detected the highest number of AF episodes
In summary data on the optimal type of ECG monitoring after AF ablation are scarce It seems that frequent short ECG recordings have more diagnostic yield than 24-hour ECG monitoring even when performed monthly or standard care with recording ECG only when symptoms suggesting AF occur However the optimal mode of monitoring is not known Such questions as whether once-a-day ECG transmission is enough and whether longer ie 7-day Holter ECG may be as valuable as daily ECG transmissions remain unanswered
Aim to compare daily ECG transmissions with repeated 7-day Holter ECG in detecting AF episodes following AF ablation
Hypothesis daily ECG recordings have significantly higher yield in AF detection than repeated 7-day Holter ECG
Methods
The study group will consists of 50 consecutive patients undergoing AF ablation in the investigators center Only patient capable of maintain ISTEL recorder and transmitting ECG will be enrolled in the study 1-2 day after catheter ablation for AF The follow-up will last 12 months The AF detection will be performed using two recording methods in each patient The number of 50 patients has been chosen based on the assumption that Holter ECG will detect AF recurrence in 15 of patients and daily transmission will detect AF recurrence in 38 patients alfa error 005 and beta error 02
Daily ECG recordings and transmissions will be performed using the HR-2000 recorder ISTEL Poland This device enables recording of 30 seconds of 6-channel ECG I II III aVR aVL aVF from 4 metal electrodes build in the recorder In order to record ECG the device is activated by a patient and attached to the thorax at the area of sternum The duration of recording may vary from 30 seconds to 3 minutes however only 30-second recordings will be used in the present study After recording ECG will be transmitted using Bluetooth to patients smartphone and then transmitted to the central station where they will be stored and analyzed Analysis will be performed on a daily basis by an experienced ECG technician not directly involved in patients recruitment and treatment The results of all recordings will be available for study team after 3 6 and 12 months after ablation at the time when concurrent Holter ECG recordings will be analyzed Only in case of serious life-threatening arrhythmias non-sustained or sustained ventricular tachycardia or pauses 6 seconds the study team will be informed immediately by a technician about the results of 30-second ECG recording in order to undertake proper action Specifically asymptomatic episodes of AF will not be unblinded to the study team in order not to interfere with medication and to allow continuing follow-up till next Holter ECG monitoring
The second method of ECG recording will be 7-day Holter ECG DMS 300-4A recorders DM Software NV USA performed 3 6 and 12 months after ablation
The patients will be allowed to record additional ECG when symptoms suggesting AF occur This may be performed by ISTEL recorder or standard 12-lead ECG if available
At each time-point 3 6 and 12 months the study team will analyze all recorded ECGs and 7-day Holter ECG and make appropriate therapeutic decisions
Anticipated results
Daily ECG recordings will detect first AF episode faster than standard Holter monitoring
ISTEL recorder will identify more patients with AF recurrence than standard Holter monitoring
ISTEL recorder will identify more patients with asymptomatic AF recurrence than standard Holter monitoring
Definitions
AF episode - episode lasting 30 seconds Study period August 2018 - August 2020
Detailed Description:
Daily ECG transmission versus serial 7-day Holter ECG for assessment of efficacy of ablation for atrial fibrillation - the AGNES-ECG study
Introduction The optimal method for the assessment of efficacy of ablation for atrial fibrillation AF has not yet been established The symptom-based evaluation is not accurate because many AF episodes are asymptomatic It has been well documented that the more frequent andor longer ECG recording the more the AF recurrences are detected However such devices for long-term ECG monitoring as implantable loop recorders are expensive whereas external ECG monitoring is not well tolerated over a period longer than one month The most frequently used approach is periodic 1-7 day Holter ECG monitoring usually performed 3 6 and 12 months after the procedure and additional standard ECG recordings when symptoms occur 1 Using this method asymptomatic AF episodes occurring between Holter ECG recordings are missed
Recently several types of external ECG recorders have been introduced enabling good quality frequent ECG recordings and transmission via mobile phones Only a few studies documented the usefulness of this method in detecting silent AF in a high-risk population 2 however the value of short but frequent ECG recordings after AF ablation has not yet been established Kimura et al 3 tested three methods for AF detection after ablation in 30 patients The follow-up lasted 6 months and each patient underwent three types of ECG recordings 1 repeated 10-second standard ECG recordings obtained during outpatient visits 2 24-hour Holter ECG performed every month and 3 short 30-second ECG recordings performed twice daily and when symptoms occur transmitted by telemetry As expected the latter method enabled detection of the highest number of AF episodes however the number of recordings declined steadily throughout the period of the study suggesting some technical difficulties with performing recordings and decreased patient compliance
Similar study was conducted by Senatore et al 4 who compared diagnostic yield of twice daily ECG tele-transmission versus repeated 24 hour ECG recordings in 72 patients after AF ablation Using daily ECG transmissions significantly more patients had AF episodes detected 278 vs 139 p 0001 In another study 5 twice daily ECG transmissions using smartphone and AliveCor system were compared with standard medical care in patients with a history of AF undergoing ablation or cardioversion Also in this study frequent ECG transmissions using smartphone occurred more effective in detecting AF recurrences than standard care 61 vs 30 P 004
In summary data on the optimal type of ECG monitoring after AF ablation are scarce It seems that frequent short ECG recordings have more diagnostic yield than 24-hour ECG monitoring even when performed monthly or standard care with recording ECG only when symptoms suggesting AF occur However the optimal mode of monitoring is not known Such questions as whether once-a-day ECG transmission is enough and whether longer ie 7-day Holter ECG may be as valuable as daily ECG transmissions remain unanswered
Aim to compare daily ECG transmissions with repeated 7-day Holter ECG in detecting AF episodes following AF ablation
Hypothesis daily ECG recordings have significantly higher yield in AF detection than repeated 7-day Holter ECG
Methods
Patients
The study group will consists of 50 consecutive patients undergoing AF ablation in the investigators center The follow-up will last 12 months The AF detection will be performed using two recording methods in each patient The number of 50 patients has been chosen based on the assumption that Holter ECG will detect AF recurrence in 15 of patients and daily transmission will detect AF recurrence in 38 patients alfa error 005 and beta error 02
Daily ECG recordings and transmissions will be performed using the HR-2000 recorder ISTEL Poland This device enables recording of 30 seconds of 6-channel ECG I II III aVR aVL aVF from 4 metal electrodes build in the recorder In order to record ECG the device is activated by a patient and attached to the thorax at the area of sternum The duration of recording may vary from 30 seconds to 3 minutes however only 30-second recordings will be used in the present study After recording ECG will be transmitted using Bluetooth to patients smartphone and then transmitted to the central station where they will be stored and analyzed Analysis will be performed on a daily basis by an experienced ECG technician not directly involved in patients recruitment and treatment The results of all recordings will be available for study team after 3 6 and 12 months after ablation at the time when concurrent Holter ECG recordings will be analyzed Only in case of serious life-threatening arrhythmias non-sustained or sustained ventricular tachycardia or pauses 6 seconds the study team will be informed immediately by a technician about the results of 30-second ECG recording in order to undertake proper action Specifically asymptomatic episodes of AF will not be unblinded to the study team in order not to interfere with medication and to allow continuing follow-up till next Holter ECG monitoring
The second method of ECG recording will be 7-day Holter ECG DMS 300-4A recorders DM Software NV USA performed 3 6 and 12 months after ablation
The patients will be allowed to record additional ECG when symptoms suggesting AF occur This may be performed by ISTEL recorder or standard 12-lead ECG if available
At each time-point 3 6 and 12 months the study team will analyze all recorded ECGs and 7-day Holter ECG and make appropriate therapeutic decisions
Inclusion criteria
1 AF ablation 1-3 days prior to inclusion
2 Access to smartphone and ability to maintain ISTEL recorder and transmitting ECG
Exclusion criteria
1 Pacemaker implanted
2 Known presence of other than AF cardiac arrhythmias requiring frequent ECG monitoring ventricular arrhythmia second or third-degree atrioventricular block
3 Lack of smartphone or inability to manage ISTEL recorder
1 Primary end-point Time to detection of first AF episode after ablation 2 Secondary end-point Number of patients with AF recurrence after ablation Number of patients with asymptomatic AF recurrence after ablation
Definitions AF episode - episode lasting 30 seconds Study period August 2018 - August 2020
Introduction The optimal method for the assessment of efficacy of ablation for atrial fibrillation AF has not yet been established The symptom-based evaluation is not accurate because many AF episodes are asymptomatic It has been well documented that the more frequent andor longer ECG recording the more the AF recurrences are detected However such devices for long-term ECG monitoring as implantable loop recorders are expensive whereas external ECG monitoring is not well tolerated over a period longer than one month The most frequently used approach is periodic 1-7 day Holter ECG monitoring usually performed 3 6 and 12 months after the procedure and additional standard ECG recordings when symptoms occur 1 Using this method asymptomatic AF episodes occurring between Holter ECG recordings are missed
Recently several types of external ECG recorders have been introduced enabling good quality frequent ECG recordings and transmission via mobile phones Only a few studies documented the usefulness of this method in detecting silent AF in a high-risk population 2 however the value of short but frequent ECG recordings after AF ablation has not yet been established Kimura et al 3 tested three methods for AF detection after ablation in 30 patients The follow-up lasted 6 months and each patient underwent three types of ECG recordings 1 repeated 10-second standard ECG recordings obtained during outpatient visits 2 24-hour Holter ECG performed every month and 3 short 30-second ECG recordings performed twice daily and when symptoms occur transmitted by telemetry As expected the latter method enabled detection of the highest number of AF episodes however the number of recordings declined steadily throughout the period of the study suggesting some technical difficulties with performing recordings and decreased patient compliance
Similar study was conducted by Senatore et al 4 who compared diagnostic yield of twice daily ECG tele-transmission versus repeated 24 hour ECG recordings in 72 patients after AF ablation Using daily ECG transmissions significantly more patients had AF episodes detected 278 vs 139 p 0001 In another study 5 twice daily ECG transmissions using smartphone and AliveCor system were compared with standard medical care in patients with a history of AF undergoing ablation or cardioversion Also in this study frequent ECG transmissions using smartphone occurred more effective in detecting AF recurrences than standard care 61 vs 30 P 004
In summary data on the optimal type of ECG monitoring after AF ablation are scarce It seems that frequent short ECG recordings have more diagnostic yield than 24-hour ECG monitoring even when performed monthly or standard care with recording ECG only when symptoms suggesting AF occur However the optimal mode of monitoring is not known Such questions as whether once-a-day ECG transmission is enough and whether longer ie 7-day Holter ECG may be as valuable as daily ECG transmissions remain unanswered
Aim to compare daily ECG transmissions with repeated 7-day Holter ECG in detecting AF episodes following AF ablation
Hypothesis daily ECG recordings have significantly higher yield in AF detection than repeated 7-day Holter ECG
Methods
Patients
The study group will consists of 50 consecutive patients undergoing AF ablation in the investigators center The follow-up will last 12 months The AF detection will be performed using two recording methods in each patient The number of 50 patients has been chosen based on the assumption that Holter ECG will detect AF recurrence in 15 of patients and daily transmission will detect AF recurrence in 38 patients alfa error 005 and beta error 02
Daily ECG recordings and transmissions will be performed using the HR-2000 recorder ISTEL Poland This device enables recording of 30 seconds of 6-channel ECG I II III aVR aVL aVF from 4 metal electrodes build in the recorder In order to record ECG the device is activated by a patient and attached to the thorax at the area of sternum The duration of recording may vary from 30 seconds to 3 minutes however only 30-second recordings will be used in the present study After recording ECG will be transmitted using Bluetooth to patients smartphone and then transmitted to the central station where they will be stored and analyzed Analysis will be performed on a daily basis by an experienced ECG technician not directly involved in patients recruitment and treatment The results of all recordings will be available for study team after 3 6 and 12 months after ablation at the time when concurrent Holter ECG recordings will be analyzed Only in case of serious life-threatening arrhythmias non-sustained or sustained ventricular tachycardia or pauses 6 seconds the study team will be informed immediately by a technician about the results of 30-second ECG recording in order to undertake proper action Specifically asymptomatic episodes of AF will not be unblinded to the study team in order not to interfere with medication and to allow continuing follow-up till next Holter ECG monitoring
The second method of ECG recording will be 7-day Holter ECG DMS 300-4A recorders DM Software NV USA performed 3 6 and 12 months after ablation
The patients will be allowed to record additional ECG when symptoms suggesting AF occur This may be performed by ISTEL recorder or standard 12-lead ECG if available
At each time-point 3 6 and 12 months the study team will analyze all recorded ECGs and 7-day Holter ECG and make appropriate therapeutic decisions
Inclusion criteria
1 AF ablation 1-3 days prior to inclusion
2 Access to smartphone and ability to maintain ISTEL recorder and transmitting ECG
Exclusion criteria
1 Pacemaker implanted
2 Known presence of other than AF cardiac arrhythmias requiring frequent ECG monitoring ventricular arrhythmia second or third-degree atrioventricular block
3 Lack of smartphone or inability to manage ISTEL recorder
1 Primary end-point Time to detection of first AF episode after ablation 2 Secondary end-point Number of patients with AF recurrence after ablation Number of patients with asymptomatic AF recurrence after ablation
Definitions AF episode - episode lasting 30 seconds Study period August 2018 - August 2020
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