Who is sponsoring NCT05443594?

NCT05443594 is sponsored by Boston Scientific Corporation.

What drugs are being tested in NCT05443594?

Interventions in NCT05443594: Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System.

What condition does NCT05443594 study?

NCT05443594 studies Persistent Atrial Fibrillation.

Is NCT05443594 still recruiting?

NCT05443594 is currently completed. Last updated 16 December 2025.

Are results published for NCT05443594?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-12-16 · How we verify

NCT05443594: ADVANTAGE AF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation

Completed NA Results posted Last updated 16 December 2025

What this trial tests

NA trial testing Phase 1: FARAPULSE Ablation System in Persistent Atrial Fibrillation in 669 participants. Completed in 11 February 2025.

Timeline

28 February 2023

Primary endpoint
11 February 2025

11 February 2025

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	669
Start date	28 February 2023
Primary completion	11 February 2025
Estimated completion	11 February 2025
Sites	44 locations across Belgium, Canada, United States, Spain

Drugs / interventions tested

Phase 1: FARAPULSE Ablation System
Phase 2: FARAPULSE Ablation System

Conditions studied

Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure Primary · Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)

Phase 1: Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Cardiac tamponade / perforation * Pericarditis Through 360 Days Post-Procedure: * PV stenosis * Atrio-esophageal fistula Phase 2 Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic n

Group	Value	95% CI
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects	2.3	NA – 5.1
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects	2.4	NA – 5.2

Primary Effectiveness Endpoint: Treatment Success Rate Through Day 360 Primary · Post-Blanking Period: Day 90 through Day 360

Includes both Acute Procedural Success and Chronic Success through Day 360.

Group	Value	95% CI
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects	63.5	57.3 – NA
Pulse Field Ablation (Phase 2) Non-Roll In Treatment Subject	73.4	67.5 – NA

Rate of Persistent AF Chronic Success Secondary · Post-Blanking Period: Day 90 through Day 360

Defined as the freedom from any of the following through the Day 360 Assessment after the Blanking Period, excluding documented CTI-dependent AFL for phase 1 and for Phase 2 excluding documented CTI-dependent AFL if the participant did not have a CTI ablation with a FARAPOINT PFA Catheter: 1. Arrhythmia: Occurrence of any Detectable AF, AFL or AT 2. Re-ablation: Any re-ablation for AF, AFL or AT 3. Cardioversion: Any electrical cardioversion for AF, AFL or AT 4. AAD Use: Use of a Non-Failed Class I / III AAD or amiodarone

Group	Value	95% CI
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects	64.2	58.1 – 70.1
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects	73.4	67.5 – 78.4

Rate of Persistent AF Acute Procedural Success Secondary · Assessed through Index Ablation Procedure

* The isolation of all attempted PVs as clinically assessed at the end of the procedure by entrance block performed with or without adenosine testing, AND * The isolation of the left atrial PW as clinically assessed at the end of the procedure, performed with or without adenosine testing, via interrogation by multipolar diagnostic catheter or 3D electroanatomical mapping. * Use of an ablation catheter other than the FARAWAVE Pulse Field Ablation Catheter (i.e., use of a non-study catheter) to achieve Pulmonary Vein Isolation and Posterior Wall Isolation.

Group	Value	95% CI
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects	99.6	97.9 – 100
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects	99.6	97.8 – 100

Freedom From Documented Symptomatic Recurrence and Intervention Secondary · Post-Blanking Period: Day 90 through Day 360

Freedom from symptomatic recurrence and intervention is Chronic Treatment Success, as defined for the Primary Effectiveness Endpoint, but excluding failure due to asymptomatic detectable AF, AFL, or AT.

Group	Value	95% CI
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects	85.3	80.3 – NA
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects	81.0	75.5 – 85.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Through Day 360. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects

Serious: 44/260 (17%)

Deaths: 0/260

Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects

Serious: 53/255 (21%)

Deaths: 2/255

Serious adverse events (58 terms)

Reaction	System	Pulsed Field Ablation (Pha…	Pulsed Field Ablation (Pha…
Atrial Fibrillation	Cardiac disorders	—	—
Musculoskeletal	Musculoskeletal and connective tissue disorders	—	—
Sinus bradycardia	Cardiac disorders	—	—
Gastrointestinal	Gastrointestinal disorders	—	—
Procedure related Genitourinary/ renal	Surgical and medical procedures	—	—
Abnormal laboratory values	Surgical and medical procedures	—	—
Atrial Flutter	Cardiac disorders	—	—
Genitourinary	Renal and urinary disorders	—	—
Procedure related heart failure	Surgical and medical procedures	—	—
Adverse reaction-Medication	Surgical and medical procedures	—	—
Atrial tachycardia/ Other SVT (AVRT, AVNRT, EAT)	Cardiac disorders	—	—
Cerebrovascular Accident (CVA)	Nervous system disorders	—	—
Cerebrovascular Accident (CVA)- Hemorrhagic	Nervous system disorders	—	—
Coronary artery Disease	Cardiac disorders	—	—
Exacerbation of existing condition	General disorders	—	—
Procedure related Pulmonary (including cough, hemoptysis)	Surgical and medical procedures	—	—
Chest pain - Other	General disorders	—	—
Dyspnea - Heart Failure	Cardiac disorders	—	—
Infection - Unrelated procedure/device	Infections and infestations	—	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—	—
Stroke	Injury, poisoning and procedural complications	—	—
2nd degree AV block	Cardiac disorders	—	—
Cancer	Infections and infestations	—	—
Coronary artery injury/ spasm	Cardiac disorders	—	—
Dyspnea	Cardiac disorders	—	—

Other adverse events (70 terms — click to expand)

Reaction	System	Pulsed Field Ablation (Pha…	Pulsed Field Ablation (Pha…
Procedure related Genitourinary/Renal	Injury, poisoning and procedural complications	—	—
Atrial Fibrillation	Cardiac disorders	—	—
Procedure related Anesthesia/Sedation	Injury, poisoning and procedural complications	—	—
Oozing/Bleeding	Injury, poisoning and procedural complications	—	—
Hematoma	Injury, poisoning and procedural complications	—	—
Sinus bradycardia	Cardiac disorders	—	—
Bruising access site	Injury, poisoning and procedural complications	—	—
Fluid volume overload	Injury, poisoning and procedural complications	—	—
Pain (Non-cardiovascular)	Injury, poisoning and procedural complications	—	—
Post procedure wound discomfort	Injury, poisoning and procedural complications	—	—
Procedure related Abnormal labs	Injury, poisoning and procedural complications	—	—
Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)	Injury, poisoning and procedural complications	—	—
Atrial tachycardia/ Other SVT(AVRT, AVNRT, EAT)	Cardiac disorders	—	—
Genitourinary	Renal and urinary disorders	—	—
Atrial flutter, not specified	Cardiac disorders	—	—
Gastrointestinal	Gastrointestinal disorders	—	—
Heart Failure symptoms - Unspecified	Cardiac disorders	—	—
Pain cardiovascular (Non-ischemic)	Injury, poisoning and procedural complications	—	—
Procedure related Gastrointestinal	Injury, poisoning and procedural complications	—	—
Procedure related Hypotension	Injury, poisoning and procedural complications	—	—
Edema	General disorders	—	—
Hypertension/ hypertensive crisis	Cardiac disorders	—	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—	—
1st degree AV block	Cardiac disorders	—	—
Adverse reaction - Medication	General disorders	—	—
Angina/Chest pain	Injury, poisoning and procedural complications	—	—
Chest pain - Ischemic	General disorders	—	—
Edema	Injury, poisoning and procedural complications	—	—
Hemolysis (Laboratory confirmed)	Injury, poisoning and procedural complications	—	—
Musculoskeletal	Musculoskeletal and connective tissue disorders	—	—
Pericarditis	Injury, poisoning and procedural complications	—	—
Procedure related Genitourinary	Injury, poisoning and procedural complications	—	—
Procedure related Pulmonary (including cough, hemoptysis)	Injury, poisoning and procedural complications	—	—
AV block (permanent)	Cardiac disorders	—	—
Atrial flutter	Cardiac disorders	—	—
Chest pain - Ischemic	Vascular disorders	—	—
Fatigue/ weakness	General disorders	—	—
Multiple heart failure symptoms	Cardiac disorders	—	—
Peripheral edema - Heart Failure	General disorders	—	—
Syncope	Cardiac disorders	—	—

Most-reported serious reactions: Atrial Fibrillation, Musculoskeletal, Sinus bradycardia, Gastrointestinal, Procedure related Genitourinary/ renal, Abnormal laboratory values, Atrial Flutter, Genitourinary.

Data from ClinicalTrials.gov NCT05443594 adverse events section.

Sponsor's own description

The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Left Atrial Posterior Wall Isolation with Pulsed Field Ablation in Persistent Atrial Fibrillation.
Gunawardene MA, Frommeyer G, Ellermann C, Jularic M, et al · · 2023 · cited 33× · PMID 37834948 · DOI 10.3390/jcm12196304
Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF.
Reddy VY, Gerstenfeld EP, Schmidt B, Nair D, et al · · 2025 · cited 28× · PMID 40306839 · DOI 10.1016/j.jacc.2025.03.515
Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up: ADVANTAGE AF Phase 2.
Reddy VY, Gerstenfeld EP, Schmidt B, Andrade JG, et al · · 2025 · cited 25× · PMID 40273320 · DOI 10.1161/circulationaha.125.074485
Pulsed Field Ablation of Atrial Fibrillation: A Comprehensive Review.
Matos CD, Hoyos C, Miranda-Arboleda AF, Diaz JC, et al · · 2023 · cited 9× · PMID 39076426 · DOI 10.31083/j.rcm2411337
Pulsed Field Ablation vs Standard Radiofrequency Ablation for Typical Atrial Flutter: ADVANTAGE AF Trial Substudy.
Gerstenfeld EP, Schmidt B, Natale A, Nair D, et al · · 2026 · PMID 41653174 · DOI 10.1016/j.jacc.2025.12.081
Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation.
Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, et al · · 2026 · PMID 40928625 · DOI 10.1007/s10840-025-02124-6
Use of a Focal Pulsed Field Ablation Catheter to Target Premature Ventricular Contractions From the Papillary Muscle.
Saleem M, Jin C, Malyshev Y, Maan A, et al · · 2025 · PMID 40645692 · DOI 10.1016/j.jaccas.2025.104031

Verify or expand the search:

Other recruiting trials for Persistent Atrial Fibrillation

Currently open trials in the same condition.

NCT07298473 — Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sp · NA · recruiting
NCT07535268 — REPRESENT-PF Registry · recruiting
NCT07508618 — Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule · Phase 4 · recruiting
NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
NCT07106970 — PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II) · NA · recruiting

Other Boston Scientific Corporation trials

Trials by the same sponsor.

NCT07458243 — Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT · not yet recruiting
NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy · NA · not yet recruiting
NCT07276815 — OverStitch NXT Endoscopic Suture System · NA · not yet recruiting
NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure · NA · not yet recruiting
NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05443594 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 16 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05443594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing