Evaluation of Novel Waveforms Delivered Using the FARAPULSEâ„¢ PFA System (NCT07444320) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Novel Waveforms Delivered Using the FARAPULSEâ„¢ PFA System
Croatia, Czechia, Hong Kong200 participantsStarted 2026-02-12
Plain-language summary
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age, or older if required by local law
✓. Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation
✓. Persistent AF Documented:
✓. Paroxysmal AF Documented:
✓. Willing and capable of providing informed consent
✓. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Exclusion criteria
✕. Atrial exclusions - any of the following atrial conditions:
✕. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter is not available, LA non-indexed volume \> 100 mL. If both values are available, only the LA diameter will be used to confirm eligibility.
✕. Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation
✕. Any prior atrial surgery
✕. Current atrial myxoma
✕. Current Left Atrial Thrombus
✕. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
What they're measuring
1
Device or procedure-related Composite Adverse Events (CAEs)
Timeframe: Ablation Procedure Day 0 - Day 7; Day 0 - Day 30; Day 0 - Day 60