An interventional study of Ablation of atrial fibrillation (AF) in Atrial Fibrillation, sponsored by Asklepios proresearch. Recruiting at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Asklepios proresearch · Not applicable, Interventional, and Treatment
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.
Atrial fibrillation (AF) is a progressive arrhythmia associated with significant morbidity and mortality and burden for our health care system. Early rhythm-control therapy was beneficial regarding cardiovascular outcomes in patients with symptomatic and asymptomatic AF. Recent studies introducing first line Cryo Balloon based catheter ablation EARLY-AF and STOP -AF provided strong evidence supporting early catheter ablation over pharmacologic rhythm control in the paroxysmal setting of AF. Ongoing studies are challenging the current concept investigating the expansion of early rhythm control also to all types of clinically diagnosed AF using cryo ablation. With the advent of pulsed field ablation (PFA), a third energy source-alongside cryothermal and radiofrequency (RF) ablation-has been established for the effective treatment of atrial fibrillation (AF). PFA induces so-called irreversible electroporation, thereby enabling successful ablation of myocardial tissue. Different cell types exhibit varying susceptibility and threshold levels for irreversible electroporation when exposed to PFA. Carefully tailored PFA pulse trains deliver sufficient energy to induce irreversible electroporation while avoiding excessive thermal effects on the surrounding tissue. Consequently, PFA enables selective targeting of myocardial tissue while minimizing collateral injury. This characteristic may translate into improved safety and efficacy in the treatment of AF. In contrast, thermal ablation techniques such as cryoablation and RF ablation inherently rely on substantial temperature changes, either cooling or heating, which may adversely affect adjacent anatomical structures including nerves (e.g., resulting in phrenic nerve palsy), vascular structures, and extracardiac tissues such as the esophagus. The occurrence of these potentially life-threatening complications may be reduced or possibly avoided using PFA. Over recent years, various PFA catheter designs as well as different PFA energy delivery settings have been introduced to enable effective and safe pulmonary vein isolation (PVI). A broad spectrum of catheter configurations-including focal single-tip catheters, pentaspline multielectrode systems, and balloon-based technologies-has been incorporated into clinical practice. Substantial comparative data evaluating PFA against conventional thermal ablation modalities (cryoablation and RF ablation) are now available. To date, no significant differences in acute procedural success rates, procedural parameters, or clinical outcome measures have been consistently observed, although one randomized trial demonstrated a trend toward improved outcomes with PFA. Across these studies, procedure duration was significantly shorter with PFA compared with conventional thermal ablation, representing an additional potential advantage of this treatment modality. More recent studies suggest that catheter ablation-particularly PFA-based ablation-for AF patients without documented recurrence during follow-up may be associated with a reduction in overall ischemic stroke events. These findings indicate that catheter ablation of AF may confer additional benefits in preventing adverse cardiovascular outcomes compared with medical therapy alone. Even in cases of AF recurrence, catheter ablation has been shown not only to significantly reduce AF burden but also to slow the progression from paroxysmal to persistent AF, the latter generally being associated with less favorable clinical outcomes compared with ablation performed during earlier disease stages. Despite the availability of effective antiarrhythmic drug therapy for AF, long-term pharmacological treatment is frequently limited by intolerance, side effects, or insufficient efficacy in a substantial proportion of patients. Nevertheless, large, randomized trials directly comparing PFA-based AF ablation with optimized medical therapy remain scarce.
Therefore, the PULSE study aims to evaluate the impact of PFA using a balloon-based catheter system for the treatment of AF on the maintenance of sinus rhythm compared with optimized medical therapy. In addition, the study will assess AF disease progression in patients with early-stage atrial fibrillation, including both symptomatic and asymptomatic individuals with paroxysmal or early persistent AF.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 264 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Asklepios proresearch is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized in the intervention group should receive the PFA ablation within 21 days.
Procedure: Ablation of atrial fibrillation (AF)
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.
PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation
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-up
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-up
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-up
Re-hospitalization rate
Re-hospitalization rate due to cardiovascular disease (e.g. AF, worsening of heart failure)
Time frame: up to 12 months follow-up
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-up
Symptom Burden assessed by quality of life
Symptom Burden, detected by Patient Questionnaires: Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and MOCA. The Montreal Cognitive Assessment (MoCA) is used as screening instrument for cognitive dysfunction. The AFEQT questionnaire is used because it is specific to AF and validated in that subject population. From each AFEQT questionnaire, a single score will be calculated in line with AFEQT scoring guidelines and post-procedure values will be compared between the randomized arms.
Time frame: QoL will be measured at baseline and at 12 months of follow up evaluating the improvement of QoL within one year.
Procedure-related complications
Procedure-related complications, including phrenic nerve injury, pulmonary vein stenosis, esophageal injury and stroke.
Time frame: up to 12 months follow-up
HF Progression Markers
Progression of heart failure defined as trend in LV-EF and trend in BNP
Time frame: up to 12 months follow-up
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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