Atrial FibrillationAMIO-CATNCT00826826
The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation
A study testing Catheter ablation and Amiodarone in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of this study is to examine the overall effectiveness of short-time anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and long-term atrial fibrillation following an ablation procedure for atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation and Amiodarone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with symptomatic paroxysmal or persistent atrial fibrillation undergoing catheter ablation for atrial fibrillation. (persistent episodes may last no more than 12 months)
Who cannot join
- Contraindication or intolerance to amiodarone.
- Prolonged amiodarone treatment within 3 months before the planned ablation procedure.
- Previous participation in this study.
- Other cardiac arrythmias (patients with co-existing atrial flutter can be included).
- Antiarrhythmic treatment for indication other than atrial fibrillation (or atrial flutter).
- Heart failure (NYHA class III or IV or left ventricular ejection fraction < 35%).
Show all 11Show fewer
- Significant heart valve disease.
- Significant lung disease, thyroid dysfunction or liver disease.
- Inability or unwillingness to be treated with anticoagulation before and during the study.
- Females with birth giving potential
- Failure to give informed concent.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Gentofte University Hospital
Hellerup, 2900
About this study
Official title: The Effect of Short Term Amiodarone Treatment on Success Rate and Quality of Life After Catheter Ablation for Atrial Fibrillation
The purpose of this study is to examine the overall effectiveness of short-time anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and long-term atrial fibrillation following an ablation procedure for atrial fibrillation.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia, and it is associated with increased mortality and morbidity due to increased risk of stroke, poor quality of life and risk of developing heart failure.
Today, catheter ablation has become a standard procedure in the treatment of symptomatic atrial fibrillation, but so far there is no official recommendations regarding the use of antiarrythmic drugs after the procedure. Nevertheless, it is common standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent early recurrences. To our knowledge, the effect of antiarrythmic drugs following ablation for atrial fibrillation has only been evaluated in a few recent studies. None of these have evaluated the long term effect of short term antiarrythmic drug treatment. In addition, none of the trials have been conducted placebo-controlled.
In this study patients with paroxysmal or persistent atrial fibrillation will be considered for randomisation. Following the ablation procedure, patients will be randomized to receive either amiodarone or placebo for a period of 8 weeks. Clinical visits including a physical exam, 12 lead ECG recording and blood samples, will be scheduled during the follow-up time. Furthermore patients will be evaluated with Quality of Life questionaires and Holter monitoring.
The primary endpoint of the study is freedom from atrial fibrillation, atrial flutter or atrial tachycardia at 6 months follow-up.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation, Amiodarone, Placebo
- Keywords
- Atrial fibrillation, Amiodarone, Arrhythmias, Cardiac, Catheter ablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
(Pulmonary vein isolation)
AmiodaroneDrug
From the day of the catheter ablation procedure and 8 weeks forward.
PlaceboDrug
From the day of the catheter ablation procedure and 8 weeks forward.
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone | Active comparator | Not described Receives: Procedure: Catheter ablation; Drug: Amiodarone |
| Placebo | Placebo comparator | Not described Receives: Procedure: Catheter ablation; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia.
Patients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.
Measured: 6 months from ablation procedure
Secondary outcomes (7)
Quality of Life
Measured: 6 months
Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug
Measured: 6 months
Structural and electrical changes (evaluated by echocardiography and digital ECG).
Measured: 6 months
Atrial fibrillation burden evaluated by Holter monitoring
Measured: 6 months
Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.
Measured: 6 months
Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs.
Measured: 3 months
Symptom burden.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Darkner, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Stine Darkner, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletJesper H Svendsen, MD, DMSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826826
- Sponsor's protocol ID
- H-A-2008-085
- Other IDs
- H-A-2008-085, 2612-3819, 2008-004500-32, 2008
- Acronym
- AMIO-CAT
- Status last verified
- Mar 2014
- First submitted
- 20 Jan 2009
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olsen FJ, Darkner S, Chen X, Pehrson S, Johannessen A, Hansen J, Svendsen JH, Biering-Sorensen T. Effect of Amiodarone after Catheter Ablation According to Left Atrial Structure and Function: The AMIO-CAT Trial. Am J Cardiol. 2026 Jan 15;259:63-70. doi: 10.1016/j.amjcard.2025.09.017. Epub 2025 Sep 24.
PubMed 41005596
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short Term Amiodarone Treatment on Success Rate and Quality of Life After Catheter Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00826826
- Acronym / sponsor ID
- AMIO-CAT / H-A-2008-085
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Amiodarone, Arrhythmias, Cardiac, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jan 2009 (estimated)
- 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.
The purpose of this study is to examine the overall effectiveness of short-time anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and long-term atrial fibrillation following an ablation procedure for atrial fibrillation.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia, and it is associated with increased mortality and morbidity due to increased risk of stroke, poor quality of life and risk of developing heart failure.
Today, catheter ablation has become a standard procedure in the treatment of symptomatic atrial fibrillation, but so far there is no official recommendations regarding the use of antiarrythmic drugs after the procedure. Nevertheless, it is common standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent early recurrences. To our knowledge, the effect of antiarrythmic drugs following ablation for atrial fibrillation has only been evaluated in a few recent studies. None of these have evaluated the long term effect of short term antiarrythmic drug treatment. In addition, none of the trials have been conducted placebo-controlled.
In this study patients with paroxysmal or persistent atrial fibrillation will be considered for randomisation. Following the ablation procedure, patients will be randomized to receive either amiodarone or placebo for a period of 8 weeks. Clinical visits including a physical exam, 12 lead ECG recording and blood samples, will be scheduled during the follow-up time. Furthermore patients will be evaluated with Quality of Life questionaires and Holter monitoring.
The primary endpoint of the study is freedom from atrial fibrillation, atrial flutter or atrial tachycardia at 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone | Active comparator | Procedure: Catheter ablation, Drug: Amiodarone |
| Placebo | Placebo comparator | Procedure: Catheter ablation, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing catheter ablation for atrial fibrillation. (persistent episodes may last no more than 12 months)
Key exclusion criteria (11 listed)
- Contraindication or intolerance to amiodarone.
- Prolonged amiodarone treatment within 3 months before the planned ablation procedure.
- Previous participation in this study.
- Other cardiac arrythmias (patients with co-existing atrial flutter can be included).
- Antiarrhythmic treatment for indication other than atrial fibrillation (or atrial flutter).
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 |
|---|---|---|
| Catheter ablation(Pulmonary vein isolation) | Procedure or surgery | Amiodarone, Placebo |
| AmiodaroneFrom the day of the catheter ablation procedure and 8 weeks forward. | Drug | Amiodarone |
| PlaceboFrom the day of the catheter ablation procedure and 8 weeks forward. | Drug | Placebo |
Primary outcome
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia.
Time frame: 6 months from ablation procedure
Patients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.
7 secondary outcomes
Quality of Life
Time frame: 6 months
Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug
Time frame: 6 months
Structural and electrical changes (evaluated by echocardiography and digital ECG).
Time frame: 6 months
Atrial fibrillation burden evaluated by Holter monitoring
Time frame: 6 months
Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.
Time frame: 6 months
Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs.
Time frame: 3 months
Symptom burden.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Derived from this study: PubMed 41005596Olsen FJ, Darkner S, Chen X, Pehrson S, Johannessen A, Hansen J, Svendsen JH, Biering-Sorensen T. Effect of Amiodarone after Catheter Ablation According to Left Atrial Structure and Function: The AMIO-CAT Trial. Am J Cardiol. 2026 Jan 15;259:63-70. doi: 10.1016/j.amjcard.2025.09.017. Epub 2025 Sep 24.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Stine Darkner, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Jesper H Svendsen, MD, DMSc study director
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and Amiodarone in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia. (time frame: 6 months from ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826826, which also lists 1 linked publication.
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 5 Mar 2014.