Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Canada
Hamilton General Hospital
RECRUITING
Hamilton
Contact Information
Primary
Ingrid Copland
start-poaf@phri.ca
905-512-4940
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 400
Treatments
Active_comparator: Amiodarone maintenance therapy
Amiodarone 200 mg daily for four weeks
No_intervention: No Amiodarone maintenance therapy
No ongoing Amiodarone maintenance therapy for four weeks
Related Therapeutic Areas
Sponsors
Leads: Population Health Research Institute