AzTrials
AzTrials

Atrial FibrillationPULSENCT07621003

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

A study testing Ablation of atrial fibrillation (AF) in people with Atrial Fibrillation, run by Asklepios proresearch at 10 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Ablation of atrial fibrillation (AF)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
10 sitesGermany
Study dates
19 Aug 2026to 31 Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kathrin Heitmann contact

+49 40 181885 ext. 5406

ka.heitmann@asklepios.com

Nele Gessler, MD contact

+49 40 181885 ext. 5406

n.gessler@asklepios.com

10 sites in 1 country

Germany10 sites, 10 recruiting

  • HZD Bad Oeynhausen

    Bad Oeynhausen

    Philipp Sommer, MD

    Not yet recruiting

  • Uniklinik Köln

    Cologne

    Daniel Steven, MD

    Not yet recruiting

  • Uniklinik Düsseldorf

    Düsseldorf

    Obaida Rana, MD

    Not yet recruiting

  • CCB Frankfurt

    Frankfurt

    Melanie Gunawardene, MD

    Not yet recruiting

  • Uniklinik Gießen

    Giessen

    Borislav Dinov, MD

    Not yet recruiting

  • Arian Sultan

    Hamburg, 20099

    Kathrin Heitmann, +49 40181885 ext. 5406, ka.heitmann@asklepios.com

    Recruiting

  • Marien Hospital Herne

    Herne

    Christian Ukena, MD

    Not yet recruiting

  • Leipzig Herzzentrum HZL

    Leipzig

    Kerstin Bode, MD

    Not yet recruiting

  • Lukas Krankenhaus Neuss

    Neuss

    Torsten Becker, MD

    Recruiting

  • Klinikum Nürnberg

    Nuremberg

    Thomas Deneke, MD

    Not yet recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Ablation of atrial fibrillation (AF)
Keywords
Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation of atrial fibrillation (AF)Procedure or surgery

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

Study groups in NCT07621003
Study groupRoleWhat they receive
Group1: Pulsed Field-AblationActive comparatorPatients randomized in the intervention group should receive the PFA ablation within 21 days.
Receives: Procedure: Ablation of atrial fibrillation (AF)
Group 2: Usual careNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: through 9 weeks to 12 months follow-up

Secondary outcomes (7)

  1. AF Burden

    Freedom from atrial fibrillation (AF) (>30 s) through 9 weeks to 12 months follow-up

    Measured: through 9 weeks to 12 months follow-up

  2. 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

    Measured: through 9 weeks to 12 months follow-up

  3. Re-hospitalization rate

    Re-hospitalization rate due to cardiovascular disease (e.g. AF, worsening of heart failure)

    Measured: up to 12 months follow-up

  4. AF Progression Timeline

    Progression from paroxysmal to persistent AF trough 9 weeks to 12 months follow-up.

    Measured: through 9 weeks to 12 months follow-up

  5. 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.

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

  6. Procedure-related complications

    Procedure-related complications, including phrenic nerve injury, pulmonary vein stenosis, esophageal injury and stroke.

    Measured: up to 12 months follow-up

  7. HF Progression Markers

    Progression of heart failure defined as trend in LV-EF and trend in BNP

    Measured: up to 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start19 Aug 2026
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, multicenter, randomized, open-label, blinded end-point
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621003
Sponsor's protocol ID
#4523 - PULSE Study
Acronym
PULSE
Status last verified
Aug 2026
First submitted
20 May 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39150084

  • 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.

    PubMed 40008502

  • 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.

    PubMed 34447995

  • 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.

    PubMed 33197159

  • 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.

    PubMed 33197158

  • 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.

    PubMed 41766700

  • 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.

    PubMed 38977913

  • 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.

    PubMed 35550691

  • 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.

    PubMed 38701222

  • 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.

    PubMed 40163671

  • 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.

    PubMed 40294733

  • 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.

    PubMed 38597857

  • 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.

    PubMed 27516462

  • 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.

    PubMed 34978360

  • 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.

    PubMed 40235943

Questions about this trial

What is this clinical trial studying?

A study testing Ablation of atrial fibrillation (AF) in people with Atrial Fibrillation, run by Asklepios proresearch at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathrin Heitmann (+49 40 181885 ext. 5406, ka.heitmann@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from any Atrial Tachyarrhythmia (time frame: through 9 weeks to 12 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07621003, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in