PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
Recruiting · NCT07621003 · Interventional (participants receive a specific treatment) · Lead sponsor: Asklepios proresearch
View the official record on ClinicalTrials.gov →Interventions studied
Ablation of atrial fibrillation (AF)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- Left Atrial Volume Index (LAVI) \> 50mL/m2
- Severe mitral regurgitation
- Contraindications to anticoagulation therapy
- Severe pulmonary or renal disease
- Pregnancy, active cancer disease
- Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)
Where it is running
10 locations listed.
- HZD Bad Oeynhausen - Bad Oeynhausen, Germany
- Uniklinik Köln - Cologne, Germany
- Uniklinik Düsseldorf - Düsseldorf, Germany
- CCB Frankfurt - Frankfurt, Germany
- Uniklinik Gießen - Giessen, Germany
- Arian Sultan - Hamburg, Germany
- Marien Hospital Herne - Herne, Germany
- Leipzig Herzzentrum HZL - Leipzig, Germany
- Lukas Krankenhaus Neuss - Neuss, Germany
- Klinikum Nürnberg - Nuremberg, Germany