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

NCT05841056 | Recruiting Phase 3 DMC

• 1 other identifier: 2023.START-POAF
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation New Onset

Keywords

cardiac surgery; heart rhythm monitoring; amiodarone

Outcome Measures

Primary Outcomes (4)

• 3 patients per center per month

  Ability to recruit an average of 3 participants per center per month

  2 years

• Less than 10% cross-over rate

  Less than 10% cross-over rate

  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

  28 days

• 90% follow-up at 30 days

  Greater than and equal to 90% follow-up at 30 days

  At 30 days post randomization date

Secondary Outcomes (3)

• Burden of 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

  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

  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 Outcomes (8)

• Heart Failure

  90 days after randomization

• Atrial Fibrillation

  90 days after randomization

• A composite of stroke, myocardial infarction and cardiovascular death

  90 days after randomization

Study Arms (2)

Amiodarone maintenance therapy

ACTIVE COMPARATOR

Amiodarone 200 mg daily for four weeks

Drug: Amiodarone Hydrochloride 200 MG

No Amiodarone maintenance therapy

NO INTERVENTION

No ongoing Amiodarone maintenance therapy for four weeks

Interventions

Amiodarone Hydrochloride 200 MG DRUG

200 mg daily for 4 weeks

Also known as: Pacerone, Cordarone

Amiodarone maintenance therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years;
• Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, 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.

You may not qualify if:

• 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 or obstructive 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Interventions

Amiodarone

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William McIntyre, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Copland

CONTACT

905-512-4940; start-poaf@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 3, 2023
• Study Start: June 13, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)