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

May 27, 2026 updated by: Asklepios proresearch

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group1: Pulsed Field-Ablation
Patients randomized in the intervention group should receive the PFA ablation within 21 days.
Procedure: Ablation of atrial fibrillation (AF)
PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from any Atrial Tachyarrhythmia
Time Frame: through 9 weeks to 12 months follow-up
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).
through 9 weeks to 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF Burden
Time Frame: through 9 weeks to 12 months follow-up
Freedom from atrial fibrillation (AF) (>30 s) through 9 weeks to 12 months follow-up
through 9 weeks to 12 months follow-up
Burden of Atrial Tachycardia and Atrial Flutter
Time Frame: through 9 weeks to 12 months follow-up
Freedom from atrial tachycardia and atrial flutter (AFL) (>30 s) through 9 weeks to 12 months follow-up
through 9 weeks to 12 months follow-up
Re-hospitalization rate
Time Frame: up to 12 months follow-up
Re-hospitalization rate due to cardiovascular disease (e.g. AF, worsening of heart failure)
up to 12 months follow-up
AF Progression Timeline
Time Frame: through 9 weeks to 12 months follow-up
Progression from paroxysmal to persistent AF trough 9 weeks to 12 months follow-up.
through 9 weeks to 12 months follow-up
Symptom Burden assessed by quality of life
Time Frame: QoL will be measured at baseline and at 12 months of follow up evaluating the improvement of QoL within one year.

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.
QoL will be measured at baseline and at 12 months of follow up evaluating the improvement of QoL within one year.
Procedure-related complications
Time Frame: up to 12 months follow-up
Procedure-related complications, including phrenic nerve injury, pulmonary vein stenosis, esophageal injury and stroke.
up to 12 months follow-up
HF Progression Markers
Time Frame: up to 12 months follow-up
Progression of heart failure defined as trend in LV-EF and trend in BNP
up to 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Collaborators

Abbott
Atrial Fibrillation Network

Investigators

  • Principal Investigator: Arian Sultan, MD, PhD, Asklepios Klinik St. Georg
  • Principal Investigator: Stephan Willems, MD, PhD, Asklepios Klinik St. Georg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4523 - PULSE Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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