Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persist
The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
| Condition(s) | Persistant Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF). |
| Who can participate | Inclusion Criteria: 1. Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation: Paroxysmal AF (Phase A participants) 1. Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND 2. At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment Persistent AF (Phase A, B, and C participants) 1. Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND 2. Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR 3. Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart w |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | CardioFocus |
| Locations | Split, Croatia; Brno, Czechia; Prague, Czechia |
| Start date | 2023-02-27 |
| NCT ID | NCT07281521 |
| Official listing | https://clinicaltrials.gov/study/NCT07281521 |