PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study

Sponsor
Asklepios proresearch
Study ID
NCT07621003
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ablation of atrial fibrillation (AF) — PROCEDURE
    PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Aug 19, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group1: Pulsed Field-Ablation
    Patients randomized in the intervention group should receive the PFA ablation within 21 days.
  • No Intervention: Group 2: Usual care
    Patients randomized in the control group / usual care group will undergo optimal medical treatment (OMT), defined as antiarrhythmic drug therapy (AAD). Within 21 days patients in the control group should start or maintain on AAD therapy based on decision of the investigator and according to current ESC Guidelines.

Primary Outcome Measure

Freedom from any Atrial Tachyarrhythmia [ Time Frame: through 9 weeks to 12 months follow-up ]

Central Contacts

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