Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

5 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

264

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Duitsland
      • Bad Oeynhausen, Duitsland
        • Nog niet aan het werven
        • HZD Bad Oeynhausen
        • Contact:
          • Philipp Sommer, MD
      • Cologne, Duitsland
        • Nog niet aan het werven
        • Uniklinik Köln
        • Contact:
          • Daniel Steven, MD
      • Düsseldorf, Duitsland
        • Nog niet aan het werven
        • Uniklinik Düsseldorf
        • Contact:
          • Obaida Rana, MD
      • Frankfurt, Duitsland
        • Nog niet aan het werven
        • CCB Frankfurt
        • Contact:
          • Melanie Gunawardene, MD
      • Giessen, Duitsland
        • Nog niet aan het werven
        • Uniklinik Gießen
        • Contact:
          • Borislav Dinov, MD
      • Hamburg, Duitsland, 20099
      • Herne, Duitsland
        • Nog niet aan het werven
        • Marien Hospital Herne
        • Contact:
          • Christian Ukena, MD
      • Leipzig, Duitsland
        • Nog niet aan het werven
        • Leipzig Herzzentrum HZL
        • Contact:
          • Kerstin Bode, MD
      • Neuss, Duitsland
        • Werving
        • Lukas Krankenhaus Neuss
        • Contact:
          • Torsten Becker, MD
      • Nuremberg, Duitsland
        • Nog niet aan het werven
        • Klinikum Nürnberg
        • Contact:
          • Thomas Deneke, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Freedom from any Atrial Tachyarrhythmia
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AF Burden
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Asklepios proresearch

Medewerkers

Abbott
Atrial Fibrillation Network

Onderzoekers

  • Hoofdonderzoeker: Arian Sultan, MD, Asklepios Klinik St. Georg
  • Hoofdonderzoeker: Stephan Willems, MD, Asklepios Klinik St. Georg

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 augustus 2026

Primaire voltooiing (Geschat)

31 maart 2030

Studie voltooiing (Geschat)

31 maart 2031

Studieregistratiedata

Eerst ingediend

20 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • #4523 - PULSE Study

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren