Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial (START-POAF)

September 3, 2026 updated by: Population Health Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Principal Investigator:
          • Emilie Belley-Cote, MD
        • Contact:
      • Toronto, Ontario, Canada, M5B 1C9
        • Recruiting
        • St. Michael's Hospital
        • Principal Investigator:
          • Gianluigi Bisleri, MD
        • Contact:
          • Camila Mayorga Palacios

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 years;
  2. Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, or combinations thereof within 14 days of randomization;
  3. 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;
  4. Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.
  5. Expected to be ready for hospital discharge within 48 h of randomization.

Exclusion Criteria:

  1. Documented preoperative history of paroxysmal, persistent or permanent AF;
  2. Planned use of a class I or III anti-arrhythmic drug (other than study drug);
  3. Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);
  4. Known allergy to ECG adhesives;
  5. 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).
  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Amiodarone maintenance therapy
Amiodarone 200 mg daily for four weeks
Drug: Amiodarone Hydrochloride 200 MG
200 mg daily for 4 weeks
Other Names:
  • Cordarone
  • Pacerone
No Intervention: No Amiodarone maintenance therapy
No ongoing Amiodarone maintenance therapy for four weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3 patients per center per month
Time Frame: 2 years
Ability to recruit an average of 3 participants per center per month
2 years
Less than 10% cross-over rate
Time Frame: 28 days
Less than 10% cross-over rate
28 days
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
28 days
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
At 30 days post randomization date
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
In the 28 days measured by continuous ECG monitor placed on day after the participant finishes their 3-5g of loading dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Defined as percent time in atrial fibrillation
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
Time to first AF > 6 minutes, >6 hours and >24 hours reported from the continuous ECG monitor
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
Proportion of participants with at least one episode > 6 minutes, >6 hours and >24 hours reported from the continuous ECG
In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Failure
Time Frame: 90 days after randomization
Number of participants who experience heart failure
90 days after randomization
Atrial Fibrillation
Time Frame: 90 days after randomization
Number of participants who experience atrial fibrillation
90 days after randomization
A composite of stroke, myocardial infarction and cardiovascular death
Time Frame: 90 days after randomization
Number of participants who have at least one of the following: stroke, myocardial infarction or cardiovascular death
90 days after randomization
Major bleeding
Time Frame: 90 days after randomization
Number of participants who experience a major bleed
90 days after randomization
Systemic arterial embolism
Time Frame: 90 days after randomization
Number of participants who experience a systemic arterial embolism
90 days after randomization
Atrial Fibrillation Effect on QualiTy of life (AFEQT) Questionnaire
Time Frame: Collected at baseline, 30 day follow-up and 90 day follow-up
The Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) evaluates symptoms, daily activities, and treatment concerns participants have related to atrial fibrillation and will be completed on all participants
Collected at baseline, 30 day follow-up and 90 day follow-up
SF-12 Questionnaire
Time Frame: Collected at baseline, 30 day follow-up and 90 day follow-up
The SF-12 questionnaire which assesses physical and mental health will be completed on all participants
Collected at baseline, 30 day follow-up and 90 day follow-up
Electrical cardioversion
Time Frame: Randomization to 90 days
Proportion of participants who undergo electrical cardioversion
Randomization to 90 days
Electrical cardioversion
Time Frame: Randomization to 30 days
Proportion of participants who undergo electrical cardioversion
Randomization to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William McIntyre, MD, Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.START-POAF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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