PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepios proresearch
About this trial
This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\<3 years) compared to usual care, defined as OMT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation
First diagnosis of AF within the last 36 months
At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device
No prior catheter ablation for AF
Disqualifiers
Persistent AF >3 years or longstanding persistent AF
Previous AF-Ablation
Ongoing continuous AAD therapy with Amiodarone at baseline
History of failed continuous AAD therapy with > 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Ablation of atrial fibrillation (AF)
Procedure/SurgeryPFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Group1: Pulsed Field-AblationActive comparator 1 intervention
Group B: Group 2: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Freedom from any Atrial Tachyarrhythmia
Arrhythmia-free survival, defined as freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting \>30 seconds through 9 weeks to 12 months follow-up on ILR monitoring via blinded core lab or any 12 lead ECG on visits, ECG Holter monitoring, or on symptom driven event monitoring after a 8 week Blanking period (reviewed by a blinded endpoint review committee).
Time frame
through 9 weeks to 12 months follow-upSecondary outcomes
1
AF Burden
Freedom from atrial fibrillation (AF) (\>30 s) through 9 weeks to 12 months follow-up
Time frame
through 9 weeks to 12 months follow-up2
Burden of Atrial Tachycardia and Atrial Flutter
Freedom from atrial tachycardia and atrial flutter (AFL) (\>30 s) through 9 weeks to 12 months follow-up
Time frame
through 9 weeks to 12 months follow-up3
Re-hospitalization rate
Re-hospitalization rate due to cardiovascular disease (e.g. AF, worsening of heart failure)
Time frame
up to 12 months follow-up4
AF Progression Timeline
Progression from paroxysmal to persistent AF trough 9 weeks to 12 months follow-up.
Time frame
through 9 weeks to 12 months follow-upSponsors and contacts
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Source ClinicalTrials.gov