Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645249
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERIVERSION
Brief Summary:
Phase IV Population Sample size 122 patients male and female 18 yo patients with persistent atrial fibrillation referred for electrical cardioversion performed in Spain Number of Sites 4 Study Duration 15102024 - 1552026 Subject Participation Duration 2-4 months depending on the arm Description of Agent or Intervention amiodarone
Objectives
Primary To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen Secondary 1 Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone 2 To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen
Description of Study Design Multicenter randomized open clinical trial 122 Patients with persistent AF 7 days duration electively referred for CVE will be included Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy Patients will be randomized to 2 groups
1 Treatment impregnation with amiodarone starting one month before ECV 600 mgday 1st week 400 mgday 2nd week and 200 mgday thereafter until ECV
2 Treatment impregnation with amiodarone 800 mgday started 5 days before ECV Estimated Time to Complete Enrollment 13 months
Objectives
Primary To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen Secondary 1 Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone 2 To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen
Description of Study Design Multicenter randomized open clinical trial 122 Patients with persistent AF 7 days duration electively referred for CVE will be included Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy Patients will be randomized to 2 groups
1 Treatment impregnation with amiodarone starting one month before ECV 600 mgday 1st week 400 mgday 2nd week and 200 mgday thereafter until ECV
2 Treatment impregnation with amiodarone 800 mgday started 5 days before ECV Estimated Time to Complete Enrollment 13 months
Detailed Description:
43 RISK AND BENEFITS if any The study will compare two peri-ECV AAD regimens of amiodarone in the range of those recommended in the technical data sheet and label 16 For this reason the risks of participation in the study would be equivalent to those present in standard clinical practice
5 OBJECTIVES AND ENDPOINTS 51 OBJECTIVES 511 Primary Objective i To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen 512 Secondary Objectives i Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone
ii To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen 52 ENDPOINTS 521 Endpoint s for the primary objective i Reversal to sinus rhythm pre-ECV number of patients 522 Endpoint s for the secondary objectives i Days until reversal to sinus rhythm ii Maintenance of sinus rhythm at 1 month after cardioversion 53 HYPOTHESIS
1 In patients with persistent AF referred to ECV a long amiodarone impregnation regimen one month pre-CVE would induce pharmacological cardioversion in about a fifth of patients and would be superior to a short impregnation regimen 5 days
2 Reversal to SR induced by the administration of pre-CVE amiodarone may occur in a vulnerable period for embolic events in patients in whom OAC is initiated pre-CVE The use of a device that monitors the ECG daily will be useful to know when the reversion to pre-CVE RS occurs
3 The proportion of patients who maintain the SR at one month post-CVE will be similar in a long regimen vs a short regimen of pre-CVE amiodarone
6 STUDY DESIGN This is a multicenter randomized phase IV open clinical trial Patients with persistent AF 7 days duration electively referred for CVE will be selected After verifying that they meet the inclusion and exclusion criteria candidates will be invited to participate in the study Patients will receive information about the study and those who agree to participate will sign the informed consent
Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy Patients will be randomized to 2 groups
c Treatment impregnation with amiodarone starting one month before ECV 600 mgday 1st week 400 mgday 2nd week and 200 mgday thereafter until ECV
d Treatment impregnation with amiodarone 800 mgday started 5 days before ECV Patients who do not revert to SR pre-ECV will be treated with ECV Those who have pharmacologically reverted to SR or who have had a successful CVE will be treated with amiodarone 200 mgday after restoration of SR A one-month follow-up will be carried post-ECV to evaluate the maintenance of SR ECV will be carried out as per standard clinical practice with 200 J biphasic energy and if ineffective maximum energy will be used
According to the ESC clinical practice guidelines for AF adequate anticoagulation is a necessary requirement for at least 3 weeks before ECV to avoid the risk of embolism associated with cardioversion Patients on chronic anticoagulation will be started on the assigned pre-ECV amiodarone regimen after inclusion Patients who are not already receiving anticoagulant treatment will begin anticoagulant treatment with direct anticoagulants In this case they will wait 3 weeks before starting the amiodarone regimen to avoid the risk of embolism during this period
At baseline visit the patient will be given a mobile electrocardiographic monitoring device to determine which patients revert to SR and the time of reversal Patients will record a daily pre-ECV ECG strip that will be transmitted to the investigator team of each participating center During the post-ECV follow-up month patients will send a weekly ECG via the mobile monitoring device During clinical visits a physical examination ECG vital signs blood samples collection record of concomitant medication and collection of adverse events will be performed
No other AADs except beta-blockers or calcium antagonists will be allowed during the study Patients who experience recurrence of AF or adverse side effects will be discontinued from the study
5 OBJECTIVES AND ENDPOINTS 51 OBJECTIVES 511 Primary Objective i To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen 512 Secondary Objectives i Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone
ii To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen 52 ENDPOINTS 521 Endpoint s for the primary objective i Reversal to sinus rhythm pre-ECV number of patients 522 Endpoint s for the secondary objectives i Days until reversal to sinus rhythm ii Maintenance of sinus rhythm at 1 month after cardioversion 53 HYPOTHESIS
1 In patients with persistent AF referred to ECV a long amiodarone impregnation regimen one month pre-CVE would induce pharmacological cardioversion in about a fifth of patients and would be superior to a short impregnation regimen 5 days
2 Reversal to SR induced by the administration of pre-CVE amiodarone may occur in a vulnerable period for embolic events in patients in whom OAC is initiated pre-CVE The use of a device that monitors the ECG daily will be useful to know when the reversion to pre-CVE RS occurs
3 The proportion of patients who maintain the SR at one month post-CVE will be similar in a long regimen vs a short regimen of pre-CVE amiodarone
6 STUDY DESIGN This is a multicenter randomized phase IV open clinical trial Patients with persistent AF 7 days duration electively referred for CVE will be selected After verifying that they meet the inclusion and exclusion criteria candidates will be invited to participate in the study Patients will receive information about the study and those who agree to participate will sign the informed consent
Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy Patients will be randomized to 2 groups
c Treatment impregnation with amiodarone starting one month before ECV 600 mgday 1st week 400 mgday 2nd week and 200 mgday thereafter until ECV
d Treatment impregnation with amiodarone 800 mgday started 5 days before ECV Patients who do not revert to SR pre-ECV will be treated with ECV Those who have pharmacologically reverted to SR or who have had a successful CVE will be treated with amiodarone 200 mgday after restoration of SR A one-month follow-up will be carried post-ECV to evaluate the maintenance of SR ECV will be carried out as per standard clinical practice with 200 J biphasic energy and if ineffective maximum energy will be used
According to the ESC clinical practice guidelines for AF adequate anticoagulation is a necessary requirement for at least 3 weeks before ECV to avoid the risk of embolism associated with cardioversion Patients on chronic anticoagulation will be started on the assigned pre-ECV amiodarone regimen after inclusion Patients who are not already receiving anticoagulant treatment will begin anticoagulant treatment with direct anticoagulants In this case they will wait 3 weeks before starting the amiodarone regimen to avoid the risk of embolism during this period
At baseline visit the patient will be given a mobile electrocardiographic monitoring device to determine which patients revert to SR and the time of reversal Patients will record a daily pre-ECV ECG strip that will be transmitted to the investigator team of each participating center During the post-ECV follow-up month patients will send a weekly ECG via the mobile monitoring device During clinical visits a physical examination ECG vital signs blood samples collection record of concomitant medication and collection of adverse events will be performed
No other AADs except beta-blockers or calcium antagonists will be allowed during the study Patients who experience recurrence of AF or adverse side effects will be discontinued from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None