Atrial Fibrillation New OnsetPhase 3START-POAFNCT05841056
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
A Phase 3 study testing Amiodarone Hydrochloride 200 MG in people with Atrial Fibrillation New Onset, run by Population Health Research Institute at 2 sites in Canada.
Trial summary
The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Amiodarone Hydrochloride 200 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Jun 2024to 31 Mar 2031
- Phase
- Phase 3
- 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
- Aged ≥18 years;
- Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, or combinations thereof within 14 days of randomization;
- Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization;
- Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.
- Expected to be ready for hospital discharge within 48 h of randomization.
Who cannot join
- Documented preoperative history of paroxysmal, persistent or permanent AF;
- Planned use of a class I or III anti-arrhythmic drug (other than study drug);
- Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);
- Known allergy to ECG adhesives;
- Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive (Total Lung Capacity (TLC) <50% predicted) or obstructive (Forced Expiry Volume (FEV1) <49% predicted) lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block).
- Individuals who are pregnant, breastfeeding, or of childbearing potential - female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Leah Hayward, leah.hayward@phri.ca
Emilie Belley-Cote, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1C9
Camila Mayorga Palacios
Gianluigi Bisleri, MD
About this study
Official title: Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial
The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.
Read the detailed description
Atrial fibrillation (AF) is the most common abnormal heart rhythm in the world. In patients who have cardiac surgery, new AF is found as an early complication in more than one out of every four surgeries. In the weeks and months after heart surgery, patients who have new AF take a medication called amiodarone to keep their heart in rhythm as it heals. If the heart goes back into AF, patients can have symptoms of heart racing, heart failure (fluid on the lungs) or stroke. Although amiodarone is effective, it can have side effects like dizziness, nausea and slow heart rate. It may also damage the lungs, liver and thyroid gland. Many patients are not able to complete their full prescribed course after surgery. Therefore, it is crucial that the investigators find the shortest possible length of treatment with amiodarone that will keep the heart in rhythm while minimizing the chance of side effects or organ damage. The START-POAF Pilot Randomized Trial will compare two different durations of amiodarone treatment: 1) in-hospital load only and 2) in-hospital load plus 4 weeks after loading dose. All participants will wear an electrocardiogram (ECG) monitor for 4 weeks the day after they complete their loading dose. The investigators will compare the amount of AF seen on the ECG between the two groups.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Amiodarone Hydrochloride 200 MG
- Keywords
- cardiac surgery, heart rhythm monitoring, amiodarone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone Hydrochloride 200 MGDrug
Also called Pacerone, Cordarone
200 mg daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone maintenance therapy | Active comparator | Amiodarone 200 mg daily for four weeks Receives: Drug: Amiodarone Hydrochloride 200 MG |
| No Amiodarone maintenance therapy | No intervention | No ongoing Amiodarone maintenance therapy for four weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 patients per center per month
Ability to recruit an average of 3 participants per center per month
Measured: 2 years
Less than 10% cross-over rate
Less than 10% cross-over rate
Measured: 28 days
Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
Measured: 28 days
90% follow-up at 30 days
Greater than and equal to 90% follow-up at 30 days
Measured: At 30 days post randomization date
Recurrence of atrial fibrillation
AF recurrence lasting >= 30 seconds within 28 days
Measured: In the 28 days measured by continuous ECG monitor placed on day after the participant finishes their 3-5g of loading dose
Secondary outcomes (3)
Burden of atrial fibrillation
Defined as percent time in atrial fibrillation
Measured: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Time to first AF > 6 minutes, >6 hours and >24 hours
Time to first AF > 6 minutes, >6 hours and >24 hours reported from the continuous ECG monitor
Measured: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Participants with at least one episode >6 minutes, >6 hours and >24 hours
Proportion of participants with at least one episode > 6 minutes, >6 hours and >24 hours reported from the continuous ECG
Measured: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start13 Jun 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William McIntyre, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841056
- Sponsor's protocol ID
- 2023.START-POAF
- Acronym
- START-POAF
- Status last verified
- May 2026
- First submitted
- 4 Apr 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial
- ClinicalTrials.gov ID
- NCT05841056
- Acronym / sponsor ID
- START-POAF / 2023.START-POAF
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- cardiac surgery, heart rhythm monitoring, amiodarone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 3 May 2023 (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.
The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.
Detailed description
Atrial fibrillation (AF) is the most common abnormal heart rhythm in the world. In patients who have cardiac surgery, new AF is found as an early complication in more than one out of every four surgeries. In the weeks and months after heart surgery, patients who have new AF take a medication called amiodarone to keep their heart in rhythm as it heals. If the heart goes back into AF, patients can have symptoms of heart racing, heart failure (fluid on the lungs) or stroke. Although amiodarone is effective, it can have side effects like dizziness, nausea and slow heart rate. It may also damage the lungs, liver and thyroid gland. Many patients are not able to complete their full prescribed course after surgery. Therefore, it is crucial that the investigators find the shortest possible length of treatment with amiodarone that will keep the heart in rhythm while minimizing the chance of side effects or organ damage. The START-POAF Pilot Randomized Trial will compare two different durations of amiodarone treatment: 1) in-hospital load only and 2) in-hospital load plus 4 weeks after loading dose. All participants will wear an electrocardiogram (ECG) monitor for 4 weeks the day after they complete their loading dose. The investigators will compare the amount of AF seen on the ECG between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy
| Arm | Type | Receives |
|---|---|---|
| Amiodarone maintenance therapy | Active comparator | Drug: Amiodarone Hydrochloride 200 MGAmiodarone 200 mg daily for four weeks |
| No Amiodarone maintenance therapy | No intervention | –No ongoing Amiodarone maintenance therapy for four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years;
- Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, or combinations thereof within 14 days of randomization;
- Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization;
- Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.
- Expected to be ready for hospital discharge within 48 h of randomization.
Key exclusion criteria (6 listed)
- Documented preoperative history of paroxysmal, persistent or permanent AF;
- Planned use of a class I or III anti-arrhythmic drug (other than study drug);
- Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);
- Known allergy to ECG adhesives;
- Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive (Total Lung Capacity (TLC) <50% predicted) or obstructive (Forced Expiry Volume (FEV1) <49% predicted) lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block).
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 Hydrochloride 200 MGAlso: Pacerone, Cordarone200 mg daily for 4 weeks | Drug | Amiodarone maintenance therapy |
Primary outcome
3 patients per center per month
Time frame: 2 years
Ability to recruit an average of 3 participants per center per month
Less than 10% cross-over rate
Time frame: 28 days
Less than 10% cross-over rate
Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
Time frame: 28 days
Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
90% follow-up at 30 days
Time frame: At 30 days post randomization date
Greater than and equal to 90% follow-up at 30 days
Recurrence of atrial fibrillation
Time frame: In the 28 days measured by continuous ECG monitor placed on day after the participant finishes their 3-5g of loading dose
AF recurrence lasting >= 30 seconds within 28 days
3 secondary outcomes
Burden of atrial fibrillation
Time frame: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Time to first AF > 6 minutes, >6 hours and >24 hours
Time frame: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Participants with at least one episode >6 minutes, >6 hours and >24 hours
Time frame: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
William McIntyre, MD principal investigator
Population Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone Hydrochloride 200 MG in people with Atrial Fibrillation New Onset, run by Population Health Research Institute at 2 sites 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ingrid Copland (905-512-4940, start-poaf@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 patients per center per month (time frame: 2 years). The study lists 5 primary outcomes in all. 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 4 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.