Atrial Fibrillation (Paroxysmal)VISION AFNCT06828939
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
A study testing pulsed field ablation in people with Atrial Fibrillation (Paroxysmal), run by CardioFocus at 1 site in Czechia.
Trial summary
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal)
- What is being tested?
- pulsed field ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 12 Dec 2024to 31 Dec 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent symptomatic PAF with at least one documented episode
- Failure or intolerance of at least one AAD
- Age 18-75 years
- Patient is indicated for an ablation procedure according to society guidelines or study site practice
- Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study
Who cannot join
- overall good health as established by multiple criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce Hospital
Prague, Czech Republic
About this study
Official title: Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
Read the detailed description
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Being tested
- pulsed field ablation
- Keywords
- ablation, 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.
pulsed field ablationDevice
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System Receives: Device: pulsed field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint - Acute Procedure Success
Pulmonary vein isolation at the end of the index procedure
Measured: During procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified:
- AE fistula (assessed at >=60 days)
- Cardiac perforation, tamponade, or pericardial effusion
- Complete heart block
- Death
- Major vascular access complications/bleeding requiring surgical intervention or blood transfusion
- MI
- Pericarditis
- PNI resulting in persistent diaphragmatic paralysis (assessed at <=60 days)
- PV stenosis (assessed at <=60 days)
- Stroke/CVA
- Thromboembolism
- TIA
- Vagal nerve injury/gastroparesis
Measured: 7 days (unless otherwise specified)
Secondary outcomes (2)
Secondary Effectiveness Endpoint - Chronic Durability
Percentage of treated PVs with documented PVI at the remapping procedure
Measured: 90 days
Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia
Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of > 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start12 Dec 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (Paroxysmal)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
- Not applicable
- Intervention model
- Single group
- Model description
- OptiShot PFA Balloon System
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828939
- Sponsor's protocol ID
- 25-6073
- Acronym
- VISION AF
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy VY, Petru J, Funasako M, Koruth JS, Neuzil P. Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study. JACC Clin Electrophysiol. 2026 Apr 23:S2405-500X(26)00364-6. doi: 10.1016/j.jacep.2026.04.009. Online ahead of print.
PubMed 42024567
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06828939
- Acronym / sponsor ID
- VISION AF / 25-6073
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Keywords
- ablation, pulsed field ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2025 (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, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
Detailed description
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- OptiShot PFA Balloon System
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: pulsed field ablationThe treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recurrent symptomatic PAF with at least one documented episode
- Failure or intolerance of at least one AAD
- Age 18-75 years
- Patient is indicated for an ablation procedure according to society guidelines or study site practice
- Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study
Key exclusion criteria (1 listed)
- overall good health as established by multiple criteria
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 ablationPulsed field ablation using a ultra-compliant endoscopic PFA balloon. | Device | Treatment Arm |
Primary outcome
Primary Effectiveness Endpoint - Acute Procedure Success
Time frame: During procedure
Pulmonary vein isolation at the end of the index procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
Time frame: 7 days (unless otherwise specified)
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * AE fistula (assessed at >=60 days) * Cardiac perforation, tamponade, or pericardial effusion * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * MI * Pericarditis * PNI resulting in persistent diaphragmatic paralysis (assessed at <=60 days) * PV stenosis (assessed at <=60 days) * Stroke/CVA * Thromboembolism * TIA * Vagal nerve injury/gastroparesis
2 secondary outcomes
Secondary Effectiveness Endpoint - Chronic Durability
Time frame: 90 days
Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia
Time frame: 12 months
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 3 Aug 2026.
- Derived from this study: PubMed 42024567Reddy VY, Petru J, Funasako M, Koruth JS, Neuzil P. Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study. JACC Clin Electrophysiol. 2026 Apr 23:S2405-500X(26)00364-6. doi: 10.1016/j.jacep.2026.04.009. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed field ablation in people with Atrial Fibrillation (Paroxysmal), run by CardioFocus at 1 site in Czechia.
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 1 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 3 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 1 site in Czechia. 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 Vikramaditya Mediratta, MS (714-717-2376, vmediratta@cardiofocus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint - Acute Procedure Success (time frame: During procedure). 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 NCT06828939, which also lists 1 linked publication.
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 3 Aug 2026.