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

NCT07621003 | Not Yet Recruiting DMC

• 1 other identifier: #4523 - PULSE Study
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Ablation

Outcome Measures

Primary Outcomes (1)

• 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).

  through 9 weeks to 12 months follow-up

Secondary Outcomes (7)

• AF Burden

  through 9 weeks to 12 months follow-up

• Burden of Atrial Tachycardia and Atrial Flutter

  through 9 weeks to 12 months follow-up

• Re-hospitalization rate

  up to 12 months follow-up

• AF Progression Timeline

  through 9 weeks to 12 months follow-up

• Symptom Burden assessed by quality of life

  QoL will be measured at baseline and at 12 months of follow up evaluating the improvement of QoL within one year.

Study Arms (2)

Group1: Pulsed Field-Ablation

ACTIVE COMPARATOR

Patients randomized in the intervention group should receive the PFA ablation within 21 days.

Procedure: Ablation of atrial fibrillation (AF)

Group 2: Usual care

NO INTERVENTION

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.

Interventions

Ablation of atrial fibrillation (AF) PROCEDURE

PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation

Group1: Pulsed Field-Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asklepios proresearch: lead
• Atrial Fibrillation Network: collaborator
• Abbott: collaborator

Related Publications (20)

• Ito T, Noda T, Nochioka K, Shiroto T, Yamamoto N, Sato H, Chiba T, Hasebe Y, Nakano M, Takahama H, Takahashi J, Miyata S, Shimokawa H, Yasuda S. Clinical impact of atrial fibrillation progression in patients with heart failure with preserved ejection fraction: A report from the CHART-2 Study. Europace. 2024 Aug 30;26(9):euae218. doi: 10.1093/europace/euae218.

  PMID: 39150084 RESULT

• van Deutekom C, van de Lande ME, Rama R, Nguyen BO, Tieleman RG, Weberndorfer V, Hemels MEW, de Melis M, Schotten U, Linz D, Crijns HJGM, van Gelder IC, Rienstra M; RACE V Investigators. Multimorbidity Is Associated With Symptom Severity and Disease Progression in Patients with Paroxysmal Atrial Fibrillation-Data From the RACE V Study. J Am Heart Assoc. 2025 Mar 4;14(5):e034514. doi: 10.1161/JAHA.123.034514. Epub 2025 Feb 26.

  PMID: 40008502 RESULT

• Willems S, Borof K, Brandes A, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Gessler N, Goette A, Haegeli LM, Heidbuchel H, Kautzner J, Ng GA, Schnabel RB, Suling A, Szumowski L, Themistoclakis S, Vardas P, van Gelder IC, Wegscheider K, Kirchhof P. Systematic, early rhythm control strategy for atrial fibrillation in patients with or without symptoms: the EAST-AFNET 4 trial. Eur Heart J. 2022 Mar 21;43(12):1219-1230. doi: 10.1093/eurheartj/ehab593.

  PMID: 34447995 RESULT

• Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.

  PMID: 33197159 RESULT

• Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.

  PMID: 33197158 RESULT

• Gunawardene MA, Gessler N, Wohlmuth P, Steven D, Eckardt L, Hoffmann BA, Metzner A, Heeger CH, Kuniss M, Ehrlich JR, Parwani AS, Bengel P, Kalkowski C, Willems S. From the Emergency Department, Directly to Ablation of Atrial Fibrillation: Rationale and Design of the EMERGE Cryo Study. CJC Open. 2025 Dec 4;8(2):197-205. doi: 10.1016/j.cjco.2025.10.019. eCollection 2026 Feb.

  PMID: 41766700 RESULT

• Ekanem E, Neuzil P, Reichlin T, Kautzner J, van der Voort P, Jais P, Chierchia GB, Bulava A, Blaauw Y, Skala T, Fiala M, Duytschaever M, Szeplaki G, Schmidt B, Massoullie G, Neven K, Thomas O, Vijgen J, Gandjbakhch E, Scherr D, Johannessen A, Keane D, Boveda S, Maury P, Garcia-Bolao I, Anic A, Hansen PS, Raczka F, Lepillier A, Guyomar Y, Gupta D, Van Opstal J, Defaye P, Sticherling C, Sommer P, Kucera P, Osca J, Tabrizi F, Roux A, Gramlich M, Bianchi S, Adragao P, Solimene F, Tondo C, Russo AD, Schreieck J, Luik A, Rana O, Frommeyer G, Anselme F, Kreis I, Rosso R, Metzner A, Geller L, Baldinger SH, Ferrero A, Willems S, Goette A, Mellor G, Mathew S, Szumowski L, Tilz R, Iacopino S, Jacobsen PK, George A, Osmancik P, Spitzer S, Balasubramaniam R, Parwani AS, Deneke T, Glowniak A, Rossillo A, Purerfellner H, Duncker D, Reil P, Arentz T, Steven D, Olalla JJ, de Jong JSSG, Wakili R, Abbey S, Timo G, Asso A, Wong T, Pierre B, Ewertsen NC, Bergau L, Lozano-Granero C, Rivero M, Breitenstein A, Inkovaara J, Fareh S, Latcu DG, Linz D, Muller P, Ramos-Maqueda J, Beiert T, Themistoclakis S, Meininghaus DG, Stix G, Tzeis S, Baran J, Almroth H, Munoz DR, de Sousa J, Efremidis M, Balsam P, Petru J, Kuffer T, Peichl P, Dekker L, Della Rocca DG, Moravec O, Funasako M, Knecht S, Jauvert G, Chun J, Eschalier R, Futing A, Zhao A, Koopman P, Laredo M, Manninger M, Hansen J, O'Hare D, Rollin A, Jurisic Z, Fink T, Chaumont C, Rillig A, Gunawerdene M, Martin C, Kirstein B, Nentwich K, Lehrmann H, Sultan A, Bohnen J, Turagam MK, Reddy VY. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med. 2024 Jul;30(7):2020-2029. doi: 10.1038/s41591-024-03114-3. Epub 2024 Jul 8.

  PMID: 38977913 RESULT

• Camm AJ, Naccarelli GV, Mittal S, Crijns HJGM, Hohnloser SH, Ma CS, Natale A, Turakhia MP, Kirchhof P. The Increasing Role of Rhythm Control in Patients With Atrial Fibrillation: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 May 17;79(19):1932-1948. doi: 10.1016/j.jacc.2022.03.337.

  PMID: 35550691 RESULT

• Sanders P, Healy S, Emami M, Kotschet E, Miller A, Kalman JM. Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study. Europace. 2024 May 2;26(5):euae118. doi: 10.1093/europace/euae118.

  PMID: 38701222 RESULT

• Tilz RR, Chierchia GB, Gunawardene M, Sanders P, Haqqani H, Kalman J, Healy S, Purerfellner H, Neuzil P, Asensi JO, Loh P, Reddy VY, Knecht S, Jesser E, Dirckx N, Miller A, Walker D, Lakkireddy D. Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results. Europace. 2025 Mar 28;27(4):euaf072. doi: 10.1093/europace/euaf072.

  PMID: 40163671 RESULT

• Lo M, Gambhir A, Sundaram S, Sanders P, DeLurgio D, Trivedi A, Mountantonakis S, Woods C, Neuzil P, Verma A, Osca J, Loh P, Calkins H, Strouse D, Chierchia GB, Atwater B, Wenzel E, Lin W, Miller A, Lakkireddy D. Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent AF: Volt-AF IDE trial acute results. Heart Rhythm. 2025 Oct;22(10):2524-2533. doi: 10.1016/j.hrthm.2025.04.037. Epub 2025 Apr 26.

  PMID: 40294733 RESULT

• Tzeis S, Gerstenfeld EP, Kalman J, Saad EB, Shamloo AS, Andrade JG, Barbhaiya CR, Baykaner T, Boveda S, Calkins H, Chan NY, Chen M, Chen SA, Dagres N, Damiano RJ, De Potter T, Deisenhofer I, Derval N, Di Biase L, Duytschaever M, Dyrda K, Hindricks G, Hocini M, Kim YH, la Meir M, Merino JL, Michaud GF, Natale A, Nault I, Nava S, Nitta T, O'Neill M, Pak HN, Piccini JP, Purerfellner H, Reichlin T, Saenz LC, Sanders P, Schilling R, Schmidt B, Supple GE, Thomas KL, Tondo C, Verma A, Wan EY. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2024 Sep;21(9):e31-e149. doi: 10.1016/j.hrthm.2024.03.017. Epub 2024 Apr 8.

  PMID: 38597857 RESULT

• Willems S, Khairy P, Andrade JG, Hoffmann BA, Levesque S, Verma A, Weerasooriya R, Novak P, Arentz T, Deisenhofer I, Rostock T, Steven D, Rivard L, Guerra PG, Dyrda K, Mondesert B, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S, Macle L; ADVICE Trial Investigators*. Redefining the Blanking Period After Catheter Ablation for Paroxysmal Atrial Fibrillation: Insights From the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) Trial. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e003909. doi: 10.1161/CIRCEP.115.003909.

  PMID: 27516462 RESULT

• Gunawardene MA, Schaeffer BN, Jularic M, Eickholt C, Maurer T, Akbulak RO, Flindt M, Anwar O, Pape UF, Maasberg S, Gessler N, Hartmann J, Willems S. Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations. J Cardiovasc Electrophysiol. 2022 Mar;33(3):345-356. doi: 10.1111/jce.15349. Epub 2022 Jan 9.

  PMID: 34978360 RESULT

• Gunawardene MA, Hartmann J, Dickow J, Wahedi R, Harloff T, Jezuit J, Tigges EP, Jularic M, Dinov B, Gessler N, Willems S. Pulsed field ablation using a circular electrode array catheter in patients with atrial fibrillation: A workflow optimization study evaluating the role of mapping. Int J Cardiol Heart Vasc. 2025 Mar 31;58:101674. doi: 10.1016/j.ijcha.2025.101674. eCollection 2025 Jun.

  PMID: 40235943 RESULT

• Reddy VY, Gerstenfeld EP, Natale A, Whang W, Cuoco FA, Patel C, Mountantonakis SE, Gibson DN, Harding JD, Ellis CR, Ellenbogen KA, DeLurgio DB, Osorio J, Achyutha AB, Schneider CW, Mugglin AS, Albrecht EM, Stein KM, Lehmann JW, Mansour M; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671. doi: 10.1056/NEJMoa2307291. Epub 2023 Aug 27.

  PMID: 37634148 RESULT

• Reichlin T, Kueffer T, Badertscher P, Juni P, Knecht S, Thalmann G, Kozhuharov N, Krisai P, Jufer C, Maurhofer J, Heg D, Pereira TV, Mahfoud F, Servatius H, Tanner H, Kuhne M, Roten L, Sticherling C; SINGLE SHOT CHAMPION Investigators. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025 Apr 17;392(15):1497-1507. doi: 10.1056/NEJMoa2502280. Epub 2025 Mar 31.

  PMID: 40162734 RESULT

• Jais P, Neuzil P, Scherr D, Frison E, Knecht S, Boveda S, Deisenhofer I, Maury P, Deneke T, Cochet H, Rousset M, Renaudeau V, Sauer E, Sermesant M, Kautzner J, Erhard N, Wichterle D. Pulsed field vs radiofrequency ablation for paroxysmal atrial fibrillation: the BEAT PAROX-AF trial. Eur Heart J. 2026 Apr 1;47(13):1527-1537. doi: 10.1093/eurheartj/ehaf1115.

  PMID: 41568658 RESULT

• Wazni OM, Saliba WI, Nair DG, Marijon E, Schmidt B, Hounshell T, Ebelt H, Skurk C, Oza S, Patel C, Kanagasundram A, Sadhu A, Sundaram S, Osorio J, Mark G, Gupta M, DeLurgio DB, Olson J, Nielsen-Kudsk JE, Boersma LVA, Healey JS, Phillips KP, Asch FM, Wolski K, Roy K, Christen T, Sutton BS, Stein KM, Reddy VY; OPTION Trial Investigators. Left Atrial Appendage Closure after Ablation for Atrial Fibrillation. N Engl J Med. 2025 Apr 3;392(13):1277-1287. doi: 10.1056/NEJMoa2408308. Epub 2024 Nov 16.

  PMID: 39555822 RESULT

• Verma A, Birnie DH, Jiang C, Heidbuchel H, Hindricks G, Kirchhof P, Healey JS, Wang Y, Dagres N, Deyell MW, Sanders P, Pathak RK, Koopman P, Nuyens D, Novak P, Amit G, Dussault C, Makanjee B, Quinn FR, Jolly U, Iden L, Kuniss M, Sharma M, Ha A, Essebag V, Champagne J, Hill MD, Smith EE, Wells GA; OCEAN Investigators. Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation. N Engl J Med. 2026 Jan 22;394(4):323-332. doi: 10.1056/NEJMoa2509688. Epub 2025 Nov 8.

  PMID: 41211931 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arian Sultan, MD, PhD

  Asklepios Klinik St. Georg

  PRINCIPAL INVESTIGATOR

• Stephan Willems, MD, PhD

  Asklepios Klinik St. Georg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Heitmann

CONTACT

+49 40 181885; ka.heitmann@asklepios.com

Nele Gessler, MD, PhD

CONTACT

+49 40 181885; n.gessler@asklepios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ILR data will be reviewed by blinded core lab investigators. All observed primary endpoints and outcome parameters will be presented to ERC.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, randomized, open-label, blinded end-point

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2031
• Last Updated: June 2, 2026

Record last verified: 2026-05