Atrial FibrillationAdmIRENCT05293639

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

A study testing Pulse Field Ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Pulse Field Ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 362 participants
Where: 30 sitesUnited States
Study dates: 18 Apr 2022to 11 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with
At least two symptomatic AF episodes within last six months from enrollment.
At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
Failed at least one Class I or Class III antiarrhythmic drug.

Who cannot join

Previously diagnosed with persistent AF (> 7 days in duration).
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Previous surgical or catheter ablation for AF.
Patients known to require ablation outside the PV region
Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
Documented LA thrombus by imaging within 48 hours of the procedure.

Show all 27Show fewer

Documented severely compromised LVEF (<40%) by imaging within 6 months prior to enrollment
Uncontrolled heart failure or New York Heart Association Class III or IV
History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),
Documented thromboembolic event (including TIA) within the past 12 months
Previous PCI/MI within the past 2 months
Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
Valvular cardiac surgical/percutaneous procedure
Unstable angina within 6 months
Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms.
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Prior diagnosis of pulmonary vein stenosis
Pre-existing hemi diaphragmatic paralysis
Acute illness, active systemic infection, or sepsis
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
Severe mitral regurgitation
Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the IRE energy field.
Presence of a condition that precludes vascular access
Current enrollment in an investigational study evaluating another device or drug.
Women who are pregnant, lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation.
Life expectancy less than 12 months

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Piedmont Healthcare
Atlanta, Georgia, 30309
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Johns Hopkins
Baltimore, Maryland, 21231
South Shore University Hospital
Bay Shore, New York, 11706
Grandview Medical Center
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Evanston Hospital / Northshore
Evanston, Illinois, 60201
Inova Fairfax Medical Center
Falls Church, Virginia, 22042
Arrhythmia Research Group (St. Bernards)
Jonesboro, Arkansas, 72401
Cardiovascular Group of Marin/SF Med Group
Larkspur, California, 94904
Minneapolis Heart Institute
Minneapolis, Minnesota, 55414
Morristown Medical Center
Morristown, New Jersey, 07960
New York University Langone Med Center
New York, New York, 10016
New York Presbyterian Hospital
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Hoag Memorial Hospital
Newport Beach, California, 92663
Florida Hospital
Orlando, Florida, 32803
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Phoenix Cardiovascular Research
Phoenix, Arizona, 85016
Baylor Research Institute
Plano, Texas, 75093
Wakemed Heart and Vascular
Raleigh, North Carolina, 27610
Virginia Commonwealth Uninversity
Richmond, Virginia, 23285
San Diego Cardiac Center
San Diego, California, 92123
Memorial Health University Medical Center
Savannah, Georgia, 31404
Albert Einstein College of Medicine
The Bronx, New York, 10561
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)

Read the detailed description

This is a prospective, non-randomized, multi-center, clinical evaluation of the Biosense Webster IRE Ablation system to demonstrate safety and long-term effectiveness for the treatment of drug refractory symptomatic PAF. The BWI IRE Ablation System consists of the VARIPULSE™ Catheter and TRUPULSE™ Generator. In conjunction with CARTO™ 3 system, it is indicated for PVI of patients with drug refractory paroxysmal atrial fibrillation.

Conditions: Atrial Fibrillation
Being tested: Pulse Field Ablation
Keywords: Interventional, Irreversible electroporation, Paroxysmal atrial fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

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

Pulse Field AblationDevice
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Study groups in NCT05293639
Study group	Role	What they receive
Treatment Group	Experimental	PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator Receives: Device: Pulse Field Ablation

What is being measured

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

Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
Measured: From Day 0 to Day 7 post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
Measured: From Day 0 to Day 7 post catheter insertion on Day 0
Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT], or atrial flutter [AFL] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to [>=] 30 seconds on an electrocardiogram [ECG], sponsor-provided cardiac event monitor [CEM], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.
Measured: Day 91 to Day 365 post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.
Measured: Day 91 to Day 365 post catheter insertion on Day 0

Secondary outcomes (2)

Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated Health Related Quality of Life (HRQoL) and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus ([Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered*6])*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.
Measured: Baseline, and 12 months post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated HRQoL and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus ([Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered*6])*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.
Measured: Baseline, and 12 months post catheter insertion on Day 0

Timeline

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

18 Apr 202211 Dec 2023

First posted24 Mar 2022
Study start18 Apr 2022
Primary completion11 Dec 2023
Study completion11 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05293639
Sponsor's protocol ID: BWI201910
Acronym: AdmIRE
Status last verified: May 2025
First submitted: 15 Mar 2022
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Publications

Di Biase L, Reddy VY, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Osorio J, Mansour M, Calkins H, Wazni O, Natale A. Early versus late atrial fibrillation recurrence after pulsed field ablation: insights from the admIRE trial. Europace. 2025 Feb 5;27(2):euaf007. doi: 10.1093/europace/euaf007.
PubMed 39820338
Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8;150(15):1174-1186. doi: 10.1161/CIRCULATIONAHA.124.070333. Epub 2024 Sep 11.
PubMed 39258362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)
ClinicalTrials.gov ID: NCT05293639
Acronym / sponsor ID: AdmIRE / BWI201910
Conditions: Atrial Fibrillation
Keywords: Interventional, Irreversible electroporation, Paroxysmal atrial fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 18 Apr 2022 (actual)
Primary completion: 11 Dec 2023 (actual)
Study completion: 11 Dec 2023 (actual)
First posted: 24 Mar 2022 (actual)
Results: Posted 4 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Group	Experimental	Device: Pulse Field AblationPFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with
Failed at least one Class I or Class III antiarrhythmic drug.

Key exclusion criteria (27 listed)

Previously diagnosed with persistent AF (> 7 days in duration).
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Previous surgical or catheter ablation for AF.
Patients known to require ablation outside the PV region
Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulse Field AblationPFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator	Device	Treatment Group

Primary outcome

Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
Time frame: From Day 0 to Day 7 post catheter insertion on Day 0
An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
Time frame: From Day 0 to Day 7 post catheter insertion on Day 0
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
Time frame: Day 91 to Day 365 post catheter insertion on Day 0
Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT], or atrial flutter [AFL] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to [>=] 30 seconds on an electrocardiogram [ECG], sponsor-provided cardiac event monitor [CEM], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
Time frame: Day 91 to Day 365 post catheter insertion on Day 0
Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.

2 secondary outcomes

Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
Time frame: Baseline, and 12 months post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
Time frame: Baseline, and 12 months post catheter insertion on Day 0

Results and safety

Results posted to the registry on 4 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot Safety Analysis Set	21	20
Pivotal Roll-In Analysis Set	64	62
Pivotal Main Safety Analysis Set	277	269

Primary outcome: Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)

Time frame: From Day 0 to Day 7 post catheter insertion on Day 0. Count of participants. Unit: Participants

Measure	Pivotal Main Phase mITT Analysis Set n = 272
Value	8

Population analysed: mITT analysis set included all participants enrolled in the pivotal main phase who met eligibility criteria and had insertion of the study catheter. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Primary outcome: Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)

Time frame: From Day 0 to Day 7 post catheter insertion on Day 0. Count of participants. Unit: Participants

Measure	Pilot Safety Analysis Set n = 20	Pivotal Roll-In Analysis Set n = 63
Value	0	0

Population analysed: Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Primary outcome: Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia

Time frame: Day 91 to Day 365 post catheter insertion on Day 0. Count of participants. Unit: Participants

Measure	Pivotal Main Phase PP Analysis Set n = 246
Value	183

Population analysed: PP analysis set included all participants enrolled in the pivotal main phase who were treated for the study-related arrhythmia with the study catheter and without protocol deviations that would affect the scientific integrity of the study. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Primary outcome: Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia

Time frame: Day 91 to Day 365 post catheter insertion on Day 0. Count of participants. Unit: Participants

Measure	Pilot Safety Analysis Set n = 20	Pivotal Roll-In Analysis Set n = 63
Value	16	43

Population analysed: Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot Safety Analysis Set	2 of 21 (9.5%)	12 of 21 (57.1%)	0 of 21
Pivotal Roll-In Analysis Set	7 of 64 (10.9%)	23 of 64 (35.9%)	1 of 64
Pivotal Main Safety Analysis Set	31 of 277 (11.2%)	109 of 277 (39.4%)	0 of 277

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39820338Di Biase L, Reddy VY, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Osorio J, Mansour M, Calkins H, Wazni O, Natale A. Early versus late atrial fibrillation recurrence after pulsed field ablation: insights from the admIRE trial. Europace. 2025 Feb 5;27(2):euaf007. doi: 10.1093/europace/euaf007.
Derived from this study: PubMed 39258362Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8;150(15):1174-1186. doi: 10.1161/CIRCULATIONAHA.124.070333. Epub 2024 Sep 11.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Biosense Webster Inc. Clinical Trial study director

Biosense Webster, Inc.

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pulse Field Ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 30 sites in United States.

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 27 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: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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?

Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs) (time frame: From Day 0 to Day 7 post catheter insertion on Day 0). The study lists 4 primary outcomes in all. 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 NCT05293639, which also lists 2 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 25 May 2025.