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Recruiting NCT05841056

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

Conditions: Atrial Fibrillation New Onset

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 400
Sponsor: Population Health Research Institute

Location: Hamilton General Hospital Hamilton Ontario

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 Criteria

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) \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05841056). StuddyBuddy aggregates publicly available trial information.