Atrial Fibrillation (AF)Faraview RemapNCT07752771
Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy
A study testing catheter ablation in people with Atrial Fibrillation (AF) and Pulsed-field Ablation, run by Semmelweis University at 1 site in Hungary.
Trial summary
Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Pulsed-field Ablation
- What is being tested?
- catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 14 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Symptomatic paroxysmal AF
- Age >18 years
- Willingness to sign the informed consent form
Who cannot join
- Contraindication to ablation
- Contraindication of long-term anticoagulation
- Persistent AF
- History of typical or atypical flutter
- History of PVI
- History of cardiac surgery
Show all 12Show fewer
- Contraindication of cardiac MRi examination
- Pregnancy
- Active malignancy
- Life expectancy <1 year
- Valvular AF
- Reversible cause of AF (e.g. hyperthyroidism).
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module).
Primary hypothesis: High durability of PVI is achievable with minimal fluoroscopy PVI, using ICE-guided transseptal puncture and Farapulse system.
Read more
Study Design: Single-center, prospective, single-arm study. Investigator-initiated study.
Research period, expected enrollment rate: The planned research period starts in the third quarter of 2024. The expected enrollment rate is 4 patients/week. The enrollment and performance of the index procedure are expected to be completed within 1.5 - 2 months, and then three more months are required before the remap procedure.
Procedure: Standard PVI using Farapulse system and Faraview module. Follow-up: Invasive left atrial remap 3 months after the procedure. Imaging: CT and MRi scans to detect pulsed-field ablation scars before the FU procedure.
Endpoints:
- Primary endpoint: PVI durability at three months, detected by invasive left atrial remap, on a per PV basis.
- Secondary endpoints:
- Continuity and size of the scar caused by the index ablation, detected on the cardiac MRI and CT before the remap (to compare it with the remapping data)
- Door-to-door time (total time spent in the EP lab)
- Skin-to-skin procedure time: time from the first femoral vein puncture to the removal of all sheaths
- Left atrial dwelling time: time from inserting the long sheath in the left atrium to the sheath removal from the left atrium
- Ablation time: time from the first until the last ablation
- Fluoroscopy time and dose
- Occurrence of any adverse events related to the procedure during the hospital stay at the 3 months remap the procedure
- Conditions
- Atrial Fibrillation (AF), Pulsed-field Ablation
- Being tested
- catheter 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.
catheter ablationDevice
Pulmonary vein isolation using Farapulse system with Faraview mapping
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Single-arm Receives: Device: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVI durability at three months
At three months, we perform an invasive left atrial remap. The primary outcome will be pulmonary vein reconnection. The outcome measure will be the risk (incidence) of pulmonary vein reconnection. The number of reconnected pulmonary veins will be collected.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start14 Apr 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752771
- Sponsor's protocol ID
- 38555-2/KKJOG/2025
- Other IDs
- 38555-2/KKJOG/2025
- Acronym
- Faraview Remap
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy
- ClinicalTrials.gov ID
- NCT07752771
- Acronym / sponsor ID
- Faraview Remap / 38555-2/KKJOG/2025
- Conditions
- Atrial Fibrillation (AF), Pulsed-field Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 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.
Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module).
Primary hypothesis: High durability of PVI is achievable with minimal fluoroscopy PVI, using ICE-guided transseptal puncture and Farapulse system.
Study Design: Single-center, prospective, single-arm study. Investigator-initiated study.
Research period, expected enrollment rate: The planned research period starts in the third quarter of 2024. The expected enrollment rate is 4 patients/week. The enrollment and performance of the index procedure are expected to be completed within 1.5 - 2 months, and then three more months are required before the remap procedure.
Procedure: Standard PVI using Farapulse system and Faraview module. Follow-up: Invasive left atrial remap 3 months after the procedure. Imaging: CT and MRi scans to detect pulsed-field ablation scars before the FU procedure.
Endpoints:
- Primary endpoint: PVI durability at three months, detected by invasive left atrial remap, on a per PV basis.
- Secondary endpoints:
- Continuity and size of the scar caused by the index ablation, detected on the cardiac MRI and CT before the remap (to compare it with the remapping data)
- Door-to-door time (total time spent in the EP lab)
- Skin-to-skin procedure time: time from the first femoral vein puncture to the removal of all sheaths
- Left atrial dwelling time: time from inserting the long sheath in the left atrium to the sheath removal from the left atrium
- Ablation time: time from the first until the last ablation
- Fluoroscopy time and dose
- Occurrence of any adverse events related to the procedure during the hospital stay at the 3 months remap the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: catheter ablationSingle-arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic paroxysmal AF
- Age >18 years
- Willingness to sign the informed consent form
Key exclusion criteria (12 listed)
- Contraindication to ablation
- Contraindication of long-term anticoagulation
- Persistent AF
- History of typical or atypical flutter
- History of PVI
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 |
|---|---|---|
| catheter ablationPulmonary vein isolation using Farapulse system with Faraview mapping | Device | Ablation |
Primary outcome
PVI durability at three months
Time frame: 3 months
At three months, we perform an invasive left atrial remap. The primary outcome will be pulmonary vein reconnection. The outcome measure will be the risk (incidence) of pulmonary vein reconnection. The number of reconnected pulmonary veins will be collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation in people with Atrial Fibrillation (AF) and Pulsed-field Ablation, run by Semmelweis University at 1 site in Hungary.
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 3 inclusion and 12 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 7 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PVI durability at three months (time frame: 3 months). 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 7 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.