Atrial Fibrillation (AF)Phase 4PERIVERSIONNCT06645249
Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
A Phase 4 study testing Amiodarone (Antiarrhythmic drug) in people with Atrial Fibrillation (AF), run by Institut Investigacio Sanitaria Pere Virgili at 4 sites in Spain.
Trial summary
Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15/10/2024 - 15/5/2026 Subject Participation Duration: 2-4 months (depending on the arm) Description of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Amiodarone (Antiarrhythmic drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesSpain
- Study dates
- 10 Dec 2024to Oct 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old.
- Persistent atrial fibrillation (≥ 7 days duration).
- Referred for elective electrical cardioversion.
- Signing of the informed consent
Who cannot join
- Need of urgent electrical cardioversion
- Mean Heart rate \<50 bpm
- Planned ablation \< 1 month after ECV.
- Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion)
- Atrial fibrillation post-cardiac surgery
- New York Heart Association (NYHA) Class IV heart failure
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- Left ventricular ejection fraction (LVEF) ≤30%
- History of thyroid disease (hyperthyroidism or hypothyroidism)
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \> 3 x upper limit of normal (ULN)
- Allergy, intolerance, or known hypersensitivity to study medication
- Women of childbearing potential unwilling to use contraceptive measures
- Participation in another clinical trial involving investigational drugs
- Life expectancy less than 12 months
- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari de Sant Joan
Reus, 43204
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706
About this study
Official title: Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15/10/2024 - 15/5/2026 Subject Participation Duration: 2-4 months (depending on the arm) Description of Agent or Intervention: amiodarone
Objectives:
Read more
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:
- Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV).
- Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months
Read the detailed description
4.3 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.
- OBJECTIVES AND ENDPOINTS 5.1 OBJECTIVES: 5.1.1 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 5.1.2 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 5.2 ENDPOINTS 5.2.1 Endpoint (s) for the primary objective i. Reversal to sinus rhythm pre-ECV (number of patients) 5.2.2 Endpoint (s) for the secondary objectives i. Days until reversal to sinus rhythm ii. Maintenance of sinus rhythm at 1 month after cardioversion 5.3 HYPOTHESIS:
- 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).
- 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.
- 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.
- 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:
- Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV).
- Treatment impregnation with amiodarone 800 mg/day 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 mg/day 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Amiodarone (Antiarrhythmic drug)
- Keywords
- Atrial fibrillation, Electrical cardioversion, amiodarone, Pharmacological cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone (Antiarrhythmic drug)Drug
Comparing 2 regimes of amiodarone pre-electrical cardioversion witn ECG monitoring
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone orally impregnation starting one month before ECV | Experimental | Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). Receives: Drug: Amiodarone (Antiarrhythmic drug) |
| Amiodarone orally impregnation started 5 days before ECV | Active comparator | Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Receives: Drug: Amiodarone (Antiarrhythmic drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal to sinus rhythm pre-electrical cardioversion
Number of patients who revert to sinus rhythm before electrical cardioversion
Measured: From date of enrollment until the date of electrical cardioversion, up to 8 weeks
Secondary outcomes (2)
Days until reversal to sinus rhythm
Number of days from enrollment to reversion to sinus rhythm
Measured: From date of enrollment until date of electrical cardioversion, up to 8 weeks
Maintenance of sinus rhythm at 1 month after cardioversion
Number of patients who remain in sinus rhythm at 1 month after reversion to sinus rhythm (pharmacological or electrical)
Measured: From date of reversion to sinus rhythm until 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start10 Dec 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter randomized phase IV open clinical trial. Patients with persistent AF (≥7 days duration) electively referred for CVE will be selected. 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 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). d.Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Cardiology, Sociedad Espanola de Cardiologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645249
- Sponsor's protocol ID
- 2023-507201-34-00
- Other IDs
- SCC 2023, SEC/FEC-INV-CLI 23/24, 2023-507201-34-00, 2023
- Acronym
- PERIVERSION
- Status last verified
- Nov 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After requirement, IPD (without data who allow identify a subject) could be shared with other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06645249
- Acronym / sponsor ID
- PERIVERSION / 2023-507201-34-00
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, Electrical cardioversion, amiodarone, Pharmacological cardioversion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Spanish Society of Cardiology, Sociedad Espanola de Cardiologia
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Oct 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.
Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15/10/2024 - 15/5/2026 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:
- Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV).
- Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months
Detailed description
4.3 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.
- OBJECTIVES AND ENDPOINTS 5.1 OBJECTIVES: 5.1.1 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 5.1.2 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 5.2 ENDPOINTS 5.2.1 Endpoint (s) for the primary objective i. Reversal to sinus rhythm pre-ECV (number of patients) 5.2.2 Endpoint (s) for the secondary objectives i. Days until reversal to sinus rhythm ii. Maintenance of sinus rhythm at 1 month after cardioversion 5.3 HYPOTHESIS:
- 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).
- 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.
- 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.
- 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:
- Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV).
- Treatment impregnation with amiodarone 800 mg/day 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 mg/day 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter randomized phase IV open clinical trial. Patients with persistent AF (≥7 days duration) electively referred for CVE will be selected. 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 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). d.Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV.
| Arm | Type | Receives |
|---|---|---|
| Amiodarone orally impregnation starting one month before ECV | Experimental | Drug: Amiodarone (Antiarrhythmic drug)Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). |
| Amiodarone orally impregnation started 5 days before ECV | Active comparator | Drug: Amiodarone (Antiarrhythmic drug)Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18 years old.
- Persistent atrial fibrillation (≥ 7 days duration).
- Referred for elective electrical cardioversion.
- Signing of the informed consent
Key exclusion criteria (14 listed)
- Need of urgent electrical cardioversion
- Mean Heart rate \<50 bpm
- Planned ablation \< 1 month after ECV.
- Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion)
- Atrial fibrillation post-cardiac surgery
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 |
|---|---|---|
| Amiodarone (Antiarrhythmic drug)Comparing 2 regimes of amiodarone pre-electrical cardioversion witn ECG monitoring | Drug | Amiodarone orally impregnation started 5 days before ECV, Amiodarone orally impregnation starting one month before ECV |
Primary outcome
Reversal to sinus rhythm pre-electrical cardioversion
Time frame: From date of enrollment until the date of electrical cardioversion, up to 8 weeks
Number of patients who revert to sinus rhythm before electrical cardioversion
2 secondary outcomes
Days until reversal to sinus rhythm
Time frame: From date of enrollment until date of electrical cardioversion, up to 8 weeks
Maintenance of sinus rhythm at 1 month after cardioversion
Time frame: From date of reversion to sinus rhythm until 1 month later
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 2 Dec 2024.
- Individual participant dataSharing planned: Yes. After requirement, IPD (without data who allow identify a subject) could be shared with other investigators.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiodarone (Antiarrhythmic drug) in people with Atrial Fibrillation (AF), run by Institut Investigacio Sanitaria Pere Virgili at 4 sites in Spain.
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 14 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 2 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 4 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Josep M. Alegret, MD, PhD (+34 689952316, josepmaria.alegret@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal to sinus rhythm pre-electrical cardioversion (time frame: From date of enrollment until the date of electrical cardioversion, up to 8 weeks). 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 2 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.