NCT04160117

Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)

Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI): A Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation. This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.

Conditions

• Atrial Fibrillation
• Recurrence

Interventions

Type	Name	Description
DRUG	Colchicine 0.6 mg	p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
DRUG	Matching placebo	p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Timeline

• Start date: 2020-01-14
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2019-11-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: Canada