NCT07621003Recruiting
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- First submitted
- 20 May 2026
- Start date
- 19 Aug 2026
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Asklepios proresearch
- Diseases
- Atrial fibrillation
- NCT number
- NCT07621003
What you commit to
- Study type: Interventional
- Planned participants: 264
- From 19 Aug 2026 to the primary completion date, 31 Mar 2030
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous AF-Ablation
- Ongoing continuous AAD therapy with Amiodarone at baseline
- Contraindications to anticoagulation therapy
Other illness
- History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-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)
Age
- Persistent AF \>3 years or longstanding persistent AF
Other
- Left Atrial Volume Index (LAVI) \> 50mL/m2
- Severe mitral regurgitation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HZD Bad Oeynhausen Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Not yet recruiting |
| Uniklinik Köln Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Uniklinik Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Not yet recruiting |
| CCB Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Not yet recruiting |
| Uniklinik Gießen Coordinator of this site? Confirm its status | Giessen | Germany | Not yet recruiting |
| Arian Sultan Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Marien Hospital Herne Coordinator of this site? Confirm its status | Herne | Germany | Not yet recruiting |
| Leipzig Herzzentrum HZL Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Lukas Krankenhaus Neuss Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
| Klinikum Nürnberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.