Atrial FibrillationinspIRENCT04524364

A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

A study testing Pulsed Field Ablation (PFA) Therapy in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 13 sites in 8 countries.

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

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF). 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?: Pulsed Field Ablation (PFA) Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 272 participants
Where: 13 sitesin 8 countries
Study dates: 23 Aug 2020to 9 May 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 (PAF)
Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
Willing and capable of providing consent
Able and willing to comply with all pre-, post- and follow-up testing and requirements

Who cannot join

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous left atrium (LA) ablation or surgery
Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
Severe dilatation of the LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))

Trial locations and contacts

13 sites in 8 countries.

Country

City, postcode or hospital

13 sites in 8 countries

Belgium4 sites

OLV Aalst
Aalst, 9300
AZ Sint-Jan Brugge
Bruges, 8000
Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
Genk, 3600
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500

Other trials in Belgium

Austria2 sites

Medical University Graz
Graz, 8036
Ordensklinikum Linz Elisabethinen
Linz, 4020

Other trials in Austria

Canada2 sites

London Health Sciences Centre
London, Ontario, N6A 5A5
Southlake Regional Health Centre
Newmarket, ON L3Y 2P9

Other trials in Canada

Croatia1 site

University Hospital Center Split
Split, 21000

Other trials in Croatia

Czechia1 site

Nemocnice na Homolce
Prague, 150 30 District 5

Other trials in Czechia

France1 site

Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, 33600

Other trials in France

Italy1 site

Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, 70021

Other trials in Italy

Lithuania1 site

Vilnius University Hospital
Vilnius, 8661

Other trials in Lithuania

About this study

Official title: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)

Conditions: Atrial Fibrillation
Being tested: Pulsed Field Ablation (PFA) Therapy
Medical subject headings: Atrial Fibrillation

What participants receive

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

Pulsed Field Ablation (PFA) TherapyDevice
Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).

Study groups in NCT04524364
Study group	Role	What they receive
Participants with Paroxysmal Atrial Fibrillation (PAF)	Other	Participants with PAF and who are candidates for catheter ablation will be enrolled. Receives: Device: Pulsed Field Ablation (PFA) Therapy

What is being measured

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

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. The primary safety endpoint was the incidence of PAEs (within 7 days of the initial mapping and ablation procedure). PAEs included the following AEs: Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction, pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/cerebrovascular accident (CVA), thromboembolism, and transient ischemic attack (TIA).
Measured: Within 7 days post-procedure on Day 0
Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT, or AFL) recurrence based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.
Measured: From Day 91 up to Day 365 post index procedure on Day 0

Secondary outcomes (3)

Number of Participants Who Achieved Acute Procedural Success
Number of participants who achieved 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.
Measured: Day 0 (Day of procedure)
Kaplan-Meier Estimates of the Success Rate of Freedom From Documented Symptomatic Re-Occurrence of Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented symptomatic re-occurrence of atrial arrhythmia (AF, AT, or AFL) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.
Measured: From Day 91 up to Day 365 post index procedure on Day 0
Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Change from baseline in AFEQT total score was reported. The AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participants' HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1-18 evaluate HRQoL and questions 19-20 relate to participants' satisfaction with treatment. Overall or subscale scores range from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 -([sum of severity for all questions answered - number of questions answered]*100 / total number questions answered*6).
Measured: Baseline, Months 3, 6, and 12

Timeline

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

23 Aug 20209 May 2023

First posted24 Aug 2020
Study start23 Aug 2020
Primary completion9 May 2023
Study completion9 May 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: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04524364
Sponsor's protocol ID: BWI_2019_08
Other IDs: BWI_2019_08
Acronym: inspIRE
Status last verified: May 2025
First submitted: 18 Aug 2020
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 Device 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

De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE. Circ Arrhythm Electrophysiol. 2024 May;17(5):e012667. doi: 10.1161/CIRCEP.123.012667. Epub 2024 Apr 24.
PubMed 38655693
Duytschaever M, De Potter T, Grimaldi M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. doi: 10.1161/CIRCEP.122.011780. Epub 2023 Feb 3.
PubMed 36735937

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: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)
ClinicalTrials.gov ID: NCT04524364
Acronym / sponsor ID: inspIRE / BWI_2019_08
Conditions: Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 23 Aug 2020 (actual)
Primary completion: 9 May 2023 (actual)
Study completion: 9 May 2023 (actual)
First posted: 24 Aug 2020 (actual)
Results: Posted 14 May 2024

Clinical summary

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

Study design

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

Arm	Type	Receives
Participants with Paroxysmal Atrial Fibrillation (PAF)	Other	Device: Pulsed Field Ablation (PFA) TherapyParticipants with PAF and who are candidates for catheter ablation will be enrolled.

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
Willing and capable of providing consent
Able and willing to comply with all pre-, post- and follow-up testing and requirements

Key exclusion criteria (5 listed)

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous left atrium (LA) ablation or surgery
Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
Severe dilatation of the LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))

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
Pulsed Field Ablation (PFA) TherapyParticipants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).	Device	Participants with Paroxysmal Atrial Fibrillation (PAF)

Primary outcome

Number of Participants With Primary Adverse Events (PAEs)
Time frame: Within 7 days post-procedure 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. The primary safety endpoint was the incidence of PAEs (within 7 days of the initial mapping and ablation procedure). PAEs included the following AEs: Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction, pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/cerebrovascular accident (CVA), thromboembolism, and transient ischemic attack (TIA).
Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
Time frame: From Day 91 up to Day 365 post index procedure on Day 0
Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT, or AFL) recurrence based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.

3 secondary outcomes

Number of Participants Who Achieved Acute Procedural Success
Time frame: Day 0 (Day of procedure)
Kaplan-Meier Estimates of the Success Rate of Freedom From Documented Symptomatic Re-Occurrence of Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
Time frame: From Day 91 up to Day 365 post index procedure on Day 0
Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Time frame: Baseline, Months 3, 6, and 12

Results and safety

Results posted to the registry on 14 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wave I	45	40
Wave II	227	216

Primary outcome: Number of Participants With Primary Adverse Events (PAEs)

Time frame: Within 7 days post-procedure on Day 0. Count of participants. Unit: Participants

Measure	Wave I n = 40	Wave II: Main Phase n = 186	Wave II: Roll-In n = 30
Value	0	0	0

Population analysed: Wave I and Wave II (Main Phase): The full analysis set (FAS) included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of pulse field ablation \[PFA\]); Wave II (Roll-in): The Roll-In analysis set (RI AS) included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the irreversible electroporation (IRE) ablation system.

Primary outcome: Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure

Time frame: From Day 91 up to Day 365 post index procedure on Day 0. Number. Unit: Percentage of participants

Measure	Wave I n = 40	Wave II: Main Phase n = 186	Wave II: Roll-In n = 30
Value	71.8	75.6	80.0

Population analysed: Wave I and Wave II (Main Phase): The FAS included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of PFA); Wave II (Roll-in): The RI AS included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the IRE ablation system.

3 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
Wave I	3 of 40 (7.5%)	30 of 40 (75%)	0 of 40
Wave II: Main Phase	9 of 186 (4.8%)	85 of 186 (45.7%)	0 of 186
Wave II: Roll-In	2 of 30 (6.7%)	17 of 30 (56.7%)	0 of 30

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 38655693De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE. Circ Arrhythm Electrophysiol. 2024 May;17(5):e012667. doi: 10.1161/CIRCEP.123.012667. Epub 2024 Apr 24.
Derived from this study: PubMed 36735937Duytschaever M, De Potter T, Grimaldi M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. doi: 10.1161/CIRCEP.122.011780. Epub 2023 Feb 3.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device 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.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Field Ablation (PFA) Therapy in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 13 sites in 8 countries.

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 5 inclusion and 5 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 13 sites in Belgium, Austria, Canada, Croatia, Czechia and 3 more countries. 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 14 May 2024). 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?

Number of Participants With Primary Adverse Events (PAEs) (time frame: Within 7 days post-procedure on Day 0). The study lists 2 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 NCT04524364, 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.