Atrial FibrillationPhase 4AmioCAAFNCT02341105
AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation
A Phase 4 study testing Catheter ablation and Amiodarone in people with Atrial Fibrillation, run by Population Health Research Institute at 1 site in Canada.
Trial summary
Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older patients with persistent atrial fibrillation (AF). Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic AF for the composite outcome of hospitalization for cardiovascular… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- 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?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Jan 2018
- Phase
- Phase 4
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent symptomatic Atrial Fibrillation (AF)
- Age 50-80 years with persistent AF (≥1 of AF episode lasting more than a week or requiring cardioversion)
Who cannot join
- Permanent atrial fibrillation
- Prior continuous use of amiodarone of more than 2 weeks.
- Prior catheter ablation for AF.
- Have a documented resting heart (while awake) of < 50 beats per minute.
- Have a known severe liver disease.
- Are deemed not suitable for CA (LA size, comorbidities…).
- Have a severe valvular disease or have a mechanical mitral prosthesis.
- Have a life-expectancy of less than 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AMIOCAAF (AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation): a Randomized Controlled Trial - Vanguard Phase
Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older patients with persistent atrial fibrillation (AF).
Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia
Read the detailed description
This is a single centre vanguard phase prospective randomized open label study with blinded outcome adjudication.
Patients will be randomized by a central randomization system (1:1) to amiodarone or catheter ablation.
- Amiodarone will be started at a dose of 400 mg/day. After one month the dose will be lowered to 200 mg per day. Patients will be seen every six months. At each visit the dose of amiodarone will be lowered by 100 mg per week if the patient is having a good clinical response to treatment. Good clinical response will be a a clinical assessment that takes into account not only actual or possible arrhythmia recurrence but also side-effects and patient acceptability of treatment. A minimum dose of 700 mg/week will be allowed. If patient symptoms recur, the amiodarone dose may be increased but not above a dose of 200 mg/day .
- Catheter ablation of persistent AF will be done within two months using pulmonary vein isolation in all subjects
- Patient not in sinus rhythm at time randomization will undergo DC cardioversion after at least 1 month of amiodarone Rx or during CA.
Follow up: Clinical assessment will include a medical history and physical examination to be performed at baseline, and every 3 months. This will also include 12-lead ECG.
- At 3, 6, 12, 18, and 24 months: QOL questionnaire (AFEQT- Atrial Fibrillation Effect on QualiTy of life) c. Thyroid and liver function tests, chest X-ray will be obtained at regular intervals.
- Arrhythmia will be monitored using a 2-week event monitors at 6, 12, 18, 24 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation, Amiodarone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Also called Pulmonary Vein Isolation (PVI)
Pulmonary vein isolation by catheter ablation
AmiodaroneDrug
Also called Antiarrhythmic
antiarrhythmic therapy using Amiodarone
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy | Active comparator | Amiodarone treatment. Amiodarone will be given at a loading dose of 400 mg per day for two week and then lowered to 200 mg daily for 6 months at which point the dose will be lowered to 1000 mg per week. The dose of amiodarone will then be lowered every six, as long as the patient has a satisfactory response. The minimum dose will be 700 mg per week. Receives: Drug: Amiodarone |
| Catheter ablation | Active comparator | A standard pulmonary vein isolation procedure will be done. Additional ablation will be permitted (roof and mitral lines/ CFAE ) Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia.
Measured: 2 years
Secondary outcomes (3)
First recurrence of an atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor
Measured: 2 years
First recurrence of a symptomatic atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor
Measured: 2 years
Quality of life measured at 3, 6 and 12 months using the Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Guy Amit, MD, Principal investigator, Hamilton Heath Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341105
- Sponsor's protocol ID
- AmioCaAF1
- Acronym
- AmioCAAF
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2015
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMIOCAAF (AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation): a Randomized Controlled Trial - Vanguard Phase
- ClinicalTrials.gov ID
- NCT02341105
- Acronym / sponsor ID
- AmioCAAF / AmioCaAF1
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 19 Jan 2015 (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.
Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older patients with persistent atrial fibrillation (AF).
Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia
Detailed description
This is a single centre vanguard phase prospective randomized open label study with blinded outcome adjudication.
Patients will be randomized by a central randomization system (1:1) to amiodarone or catheter ablation.
- Amiodarone will be started at a dose of 400 mg/day. After one month the dose will be lowered to 200 mg per day. Patients will be seen every six months. At each visit the dose of amiodarone will be lowered by 100 mg per week if the patient is having a good clinical response to treatment. Good clinical response will be a a clinical assessment that takes into account not only actual or possible arrhythmia recurrence but also side-effects and patient acceptability of treatment. A minimum dose of 700 mg/week will be allowed. If patient symptoms recur, the amiodarone dose may be increased but not above a dose of 200 mg/day .
- Catheter ablation of persistent AF will be done within two months using pulmonary vein isolation in all subjects
- Patient not in sinus rhythm at time randomization will undergo DC cardioversion after at least 1 month of amiodarone Rx or during CA.
Follow up: Clinical assessment will include a medical history and physical examination to be performed at baseline, and every 3 months. This will also include 12-lead ECG.
- At 3, 6, 12, 18, and 24 months: QOL questionnaire (AFEQT- Atrial Fibrillation Effect on QualiTy of life) c. Thyroid and liver function tests, chest X-ray will be obtained at regular intervals.
- Arrhythmia will be monitored using a 2-week event monitors at 6, 12, 18, 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy | Active comparator | Drug: AmiodaroneAmiodarone treatment. Amiodarone will be given at a loading dose of 400 mg per day for two week and then lowered to 200 mg daily for 6 months at which point the dose will be lowered to 1000 mg per week. The dose of amiodarone will then be lowered every six, as long as the patient has a satisfactory response. The minimum dose will be 700 mg per week. |
| Catheter ablation | Active comparator | Procedure: Catheter ablationA standard pulmonary vein isolation procedure will be done. Additional ablation will be permitted (roof and mitral lines/ CFAE ) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recurrent symptomatic Atrial Fibrillation (AF)
- Age 50-80 years with persistent AF (≥1 of AF episode lasting more than a week or requiring cardioversion)
Key exclusion criteria (8 listed)
- Permanent atrial fibrillation
- Prior continuous use of amiodarone of more than 2 weeks.
- Prior catheter ablation for AF.
- Have a documented resting heart (while awake) of < 50 beats per minute.
- Have a known severe liver disease.
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 ablationAlso: Pulmonary Vein Isolation (PVI)Pulmonary vein isolation by catheter ablation | Procedure or surgery | Catheter ablation |
| AmiodaroneAlso: Antiarrhythmicantiarrhythmic therapy using Amiodarone | Drug | Medical therapy |
Primary outcome
The composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia.
Time frame: 2 years
3 secondary outcomes
First recurrence of an atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor
Time frame: 2 years
First recurrence of a symptomatic atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor
Time frame: 2 years
Quality of life measured at 3, 6 and 12 months using the Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Guy Amit, MD principal investigator
Hamilton Heath Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter ablation and Amiodarone in people with Atrial Fibrillation, run by Population Health Research Institute at 1 site in Canada.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
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?
The composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia. (time frame: 2 years). 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 9 Feb 2021.