Paroxysmal Atrial Fibrillation (PAF)PFA-VISIONNCT07772518
Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation
A study testing In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping. in people with Paroxysmal Atrial Fibrillation (PAF), run by Mitera Hospital at 8 sites in 8 countries.
Trial summary
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 1 Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of paroxysmal AF.
- Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.
Who cannot join
- Any contraindication to AF catheter ablation.
- History of previous left atrial ablation.
- Need for additional ablation beyond pulmonary vein isolation.
- Inability to provide written informed consent.
- Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.
- eGFR < 30 mL/min/1.73 m2
Show all 11Show fewer
- NYHA class III/IV heart failure
- Major cardiovascular events within 90 days
- Secondary AF owing to reversible causes
- Intracardiac thrombus or other conditions making left atrial instrumentation unsafe
- Severe valvular disease
Trial locations and contacts
8 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 8 countries
Croatia1 site, 1 recruiting
- Not yet recruiting
University Hospital Centre Zagreb (KBC Zagreb)
Zagreb
Vedran Velagić, +38512388888, vvelagic@gmail.com
Czechia1 site, 1 recruiting
- Not yet recruiting
Department of Cardiology, IKEM
Prague
Petr Peichl, +420236051111, petr.peichl@ikem.cz
Greece1 site, 1 recruiting
- Recruiting
Hygeia Hospital, 8th Cardiology Department
Athens
Stylianos Tzeis, MD, PhD, FEHRA, +302106869777, stzeis@otenet.gr
Hungary1 site, 1 recruiting
- Not yet recruiting
Heart and Vascular Center, Semmelweis University
Budapest
Nándor Szegedi, +3614591500, nandorszegedi@gmail.com
Italy1 site, 1 recruiting
- Not yet recruiting
Marche Polytechnic University / Marche University Hospital
Ancona
Michela Casella, +390712206000, m.casella@univpm.it
Poland1 site, 1 recruiting
- Not yet recruiting
Grochowski Hospital, Centre of Postgraduate Medical Education
Warsaw
Jakub Baran, +48225152733, jakub.baran1111@gmail.com
Slovakia1 site, 1 recruiting
- Not yet recruiting
Department of Arrhythmology, Institute of Cardiovascular Diseases
Banská Bystrica
Adrián Bystriansky, +421484333111, Adrian.Bystriansky@suscch.eu
Slovenia1 site, 1 recruiting
- Not yet recruiting
University Medical Centre Ljubljana (UKC Ljubljana)
Ljubljana
Matevž Jan, +38615225050, matevz.jan@kclj.si
About this study
Official title: Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
- Keywords
- atrial fibrillation, paroxysmal atrial fibrillation, intracardiac echocardiography, ICE, FARAVIEW, pulsed field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.Other
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.
| Study group | Role | What they receive |
|---|---|---|
| ICE | Other | Intracardiac echocardiography-guided group Receives: Other: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping. |
| Mapping | Other | Three-dimensional electroanatomical mapping-guided group Receives: Other: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia-free survival
Primary efficacy endpoint: Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after a blanking period of 2 months. A recurrence is defined as any episode of atrial tachyarrhythmia recorded on standard 12-lead ECG or any episode lasting ≥6 minutes on Holter monitor (or CIED with atrial sensing capabilities).
Measured: up to 12 months
Complications
Composite primary safety endpoint:
Number of participants experiencing at least one of the following prespecified complications (major safety events):
Stroke, transient ischemic attack, or systemic embolism Coronary spasm Myocardial infarction Cardiac tamponade Clinically relevant esophageal complication Clinically relevant pulmonary vein stenosis Diaphragmatic paralysis persisting for more than 6 months Acute kidney injury Bleeding requiring transfusion Major vascular complication Pericarditis or vagal nerve injury Heart failure or pulmonary edema Sudden death within 30 days of the procedure Any device- or procedure-related death
For the composite primary safety endpoint, each participant will be counted only once, regardless of the number or type of qualifying events experienced.
Measured: up to 12 months
Secondary outcomes (6)
Arrhythmia-free survial (>30 sec)
Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) lasting >30 seconds on Holter monitoring, off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after an initial blanking period of 2 months.
Measured: up to 12 months
Procedure time (min)
Time from femoral puncture to catheter removal (minutes).
Measured: Periprocedural
Left atrial dwell time (min)
Time from transseptal puncture to catheter withdrawal from the left atrium (minutes).
Measured: Periprocedural
Number of lesions
Total number of ablation lesions deployed.
Measured: Periprocedural
Fluoroscopy time (min)
Duration of fluoroscopy (minutes).
Measured: Periprocedural
Fluoroscopy dose (cGy·cm²)
Total fluoroscopy dose (measured in cGy·cm²).
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stylianos Tzeis, Mitera Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772518
- Sponsor's protocol ID
- 25-06-2026 677
- Acronym
- PFA-VISION
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)
- ClinicalTrials.gov ID
- NCT07772518
- Acronym / sponsor ID
- PFA-VISION / 25-06-2026 677
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Keywords
- atrial fibrillation, paroxysmal atrial fibrillation, intracardiac echocardiography, ICE, FARAVIEW, pulsed field ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Mitera HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICE | Other | Other: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.Intracardiac echocardiography-guided group |
| Mapping | Other | Other: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.Three-dimensional electroanatomical mapping-guided group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of paroxysmal AF.
- Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.
Key exclusion criteria (11 listed)
- Any contraindication to AF catheter ablation.
- History of previous left atrial ablation.
- Need for additional ablation beyond pulmonary vein isolation.
- Inability to provide written informed consent.
- Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.
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 |
|---|---|---|
| In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups. | Other | ICE, Mapping |
Primary outcome
Arrhythmia-free survival
Time frame: up to 12 months
Primary efficacy endpoint: Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after a blanking period of 2 months. A recurrence is defined as any episode of atrial tachyarrhythmia recorded on standard 12-lead ECG or any episode lasting ≥6 minutes on Holter monitor (or CIED with atrial sensing capabilities).
Complications
Time frame: up to 12 months
Composite primary safety endpoint: Number of participants experiencing at least one of the following prespecified complications (major safety events): Stroke, transient ischemic attack, or systemic embolism Coronary spasm Myocardial infarction Cardiac tamponade Clinically relevant esophageal complication Clinically relevant pulmonary vein stenosis Diaphragmatic paralysis persisting for more than 6 months Acute kidney injury Bleeding requiring transfusion Major vascular complication Pericarditis or vagal nerve injury Heart failure or pulmonary edema Sudden death within 30 days of the procedure Any device- or procedure-related death For the composite primary safety endpoint, each participant will be counted only once, regardless of the number or type of qualifying events experienced.
6 secondary outcomes
Arrhythmia-free survial (>30 sec)
Time frame: up to 12 months
Procedure time (min)
Time frame: Periprocedural
Left atrial dwell time (min)
Time frame: Periprocedural
Number of lesions
Time frame: Periprocedural
Fluoroscopy time (min)
Time frame: Periprocedural
Fluoroscopy dose (cGy·cm²)
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping. in people with Paroxysmal Atrial Fibrillation (PAF), run by Mitera Hospital at 8 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 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Croatia, Czechia, Greece, Hungary, Italy 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stylianos Tzeis, MD, PhD, FEHRA (+302106869777, steis@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia-free survival (time frame: up to 12 months). 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?
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 19 Aug 2026.