Trial Outcomes & Findings for A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF) (NCT NCT05552963)

NCT ID: NCT05552963

Last Updated: 2026-01-06

Results Overview

Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram \[ECG\]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 142 participants
• Primary outcome timeframe: From Day 91 up to Day 365 post-procedure on Day 0
• Results posted on: 2026-01-06

Participant Flow

Participant milestones

Measure	Irreversible Electroporation (IRE) System Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Overall Study STARTED	142
Overall Study Roll-in Participants	19
Overall Study Non-roll-in Participants	123
Overall Study Completed the Index Ablation Procedure	142
Overall Study COMPLETED	140
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Irreversible Electroporation (IRE) System Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Overall Study Lost to Follow-up	1
Overall Study Study catheter was inserted, but PF energy was not delivered due to ECG interference	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Irreversible Electroporation (IRE) System n=142 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Age, Continuous	56.9 Years STANDARD_DEVIATION 12.04 • n=142 Participants
Age, Customized <45 years	26 Participants n=142 Participants
Age, Customized Between 45 to <65 years	67 Participants n=142 Participants
Age, Customized >=65 years	49 Participants n=142 Participants
Sex: Female, Male Female	61 Participants n=142 Participants
Sex: Female, Male Male	81 Participants n=142 Participants

PRIMARY outcome

Timeframe: From Day 91 up to Day 365 post-procedure on Day 0

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=122 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants With Long-term Effectiveness	74.6 Percentage of participants Interval 66.86 to 82.32

SECONDARY outcome

Timeframe: Within 7 days post-procedure on Day 0

Population: Safety analysis set included all the enrolled participants (including both non roll-in and roll-in participants) who had the investigational devices inserted or treated.

Percentage of participants experiencing PAE were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. Primary AEs within seven days of the ablation procedure which used investigational devices per protocol, including the initial and repeat procedures were reported. PAEs included cardiac tamponade, perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischaemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, pulmonary vein stenosis, pulmonary oedema (respiratory insufficiency), vagal nerve injury/gastroparesis, pericarditis, major vascular access complication/bleeding, and atrio-esophageal fistula .

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=142 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants Experiencing Primary Adverse Event (PAE)	2.1 Percentage of participants

SECONDARY outcome

Timeframe: From day of procedure (Day 0) up to 12 months

Population: Safety analysis set included all the enrolled participants (including both non roll-in and roll-in participants) who had the investigational devices inserted or treated.

Percentage of participants with SAEs within 7 days (early-onset), 8-30 days (peri-procedural) and >30 days (late onset) of initial ablation procedure were reported. A SAE was any adverse event (AE) that resulted in a death or a serious deterioration in the health of the participant during the clinical trial, including a life-threatening illness or injury, a permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a body function; or resulted in fetal distress, foetal death or congenital abnormality, congenital anomaly, etc.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=142 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure Within 7 days (early-onset) of index ablation procedure	2.8 Percentage of participants
Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure Within 8-30 days (peri-procedural)	0.7 Percentage of participants
Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure >30 days (late onset)	6.3 Percentage of participants

SECONDARY outcome

Timeframe: On the day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter was considered as acute procedural failure.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=123 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants With Acute Procedural Success	100 Percentage of participants

SECONDARY outcome

Timeframe: On the day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=123 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants With Acute Reconnection	10.6 Percentage of participants

SECONDARY outcome

Timeframe: On the day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of PVs with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=123 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Pulmonary Veins (PVs) With Acute Reconnection	4.7 Percentage of pulmonary veins

SECONDARY outcome

Timeframe: On day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=123 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants With Pulmonary Vein (PV) Ablation	0 Percentage of participants Interval 8.52 to 75.51

SECONDARY outcome

Timeframe: From the day of procedure (Day 0) up to 12 months

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with repeated ablation within the 12 months follow up period, including timing (blanking period or after blanking) were reported. Repeat procedures for AF/AT/AFL of unknown origin plus recurrences during the blanking period (90 days post index procedure) were conducted with the investigational device for ablating PV reconnections. Repeat procedures performed after the blanking period were managed per investigator discretion using a commercially available ablation catheter and generator.

Outcome measures

Measure	Irreversible Electroporation (IRE) System n=123 Participants Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Percentage of Participants With Repeated Ablation	6.5 Percentage of participants

Adverse Events

Irreversible Electroporation (IRE) System

Serious events: 16 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Irreversible Electroporation (IRE) System n=142 participants at risk Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Ear and labyrinth disorders Vertigo	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Infections and infestations Upper respiratory tract infection	1.4% 2/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Cardiac disorders Arteriosclerosis coronary artery	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Cardiac disorders Acute myocardial infarction	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Psychiatric disorders Generalised anxiety disorder	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Psychiatric disorders Obsessive-compulsive disorder	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Vascular disorders Arteriovenous fistula	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
General disorders Puncture site haematoma	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Blood and lymphatic system disorders Anaemia	1.4% 2/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Eye disorders Vitreous haemorrhage	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Eye disorders Cataract nuclear	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Reproductive system and breast disorders Heavy menstrual bleeding	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Product Issues Device dislocation	0.70% 1/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.

Other adverse events

Measure	Irreversible Electroporation (IRE) System n=142 participants at risk Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator.
Gastrointestinal disorders Nausea	4.2% 6/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.3% 9/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Respiratory, thoracic and mediastinal disorders Cough	3.5% 5/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Cardiac disorders Supraventricular tachycardia	3.5% 5/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Renal and urinary disorders Dysuria	6.3% 9/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Renal and urinary disorders Haematuria	3.5% 5/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Psychiatric disorders Insomnia	3.5% 5/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Investigations Blood pressure increased	3.5% 5/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Infections and infestations Upper respiratory tract infection	7.7% 11/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
Infections and infestations COVID-19	3.5% 5/142 • From the time of informed consent signing through 12 months post-procedure (on Day 0) Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.

Additional Information

Executive Medical Director

Janssen Research and Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER