drugset / Trial / NCT03437356

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

NCT03437356

RandomizedParallel-groupOpen-labelTreatment

Summary

In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients). In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.

Timeline

Start
2018-02-26
Primary completion
2022-05-30
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator flecainide Small molecule 100 mg Oral
Comparator flecainide Small molecule 200 mg Oral
Comparator propafenone Unknown 225 mg Oral
Comparator propafenone Unknown 300 mg Oral
Comparator sotalol Small molecule 80 mg Oral
Comparator Amiodarone Small molecule

Indications