Atrial Fibrillation (AF)GPfIRENCT06647485
Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
A study testing PF-only PVI, Hybrid PVI and RF-only PVI in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by VZW Cardiovascular Research Center Aalst at 1 site in Belgium.
Trial summary
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation (AF), Paroxysmal AF
- What is being tested?
- PF-only PVI, Hybrid PVI and RF-only PVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jan 2025to Dec 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
- Age range: 18-70 years
- Willing and capable of providing informed consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- Previously diagnosed Persistent AF (\> 7 days in duration)
- Previous LA ablation
- Previous cardiac surgery
- Myocardial Infarction within the previous 3 months
- Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
- Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
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- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Severe mitral regurgitation
- Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
OLV Hospital
Aalst, Belgium, 9300
Hedwig Batjoens, MSc, +32 53 72 44 49, hedwig.batjoens@olvz-aalst.be
About this study
Official title: A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF
- Being tested
- PF-only PVI, Hybrid PVI, RF-only PVI
- Keywords
- vagal modulation, ganglionated plexi, pulsed field, dual-energy focal ablation, paroxysmal atrial fibrillation, heart rate variability, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-only PVIProcedure or surgery
It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only PF energy for ablation
Hybrid PVIProcedure or surgery
It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing both PF and RF energy for ablation. Specifically, PF energy is used for the posterior segments and RF energy for the anterior segments of the pulmonary veins
RF-only PVIProcedure or surgery
It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only RF energy for ablation
| Study group | Role | What they receive |
|---|---|---|
| PF-only | Experimental | The PF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only PF energy Receives: Procedure: PF-only PVI |
| Hybrid (PF posterior/RF anterior) | Experimental | The Hybrid arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using both PF and RF energy Receives: Procedure: Hybrid PVI |
| RF-only | Active comparator | The RF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only RF energy Receives: Procedure: RF-only PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute HRV variation (PF-only vs. RF-only arm)
It is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the PF-only arm and the control arm (RF-only).
Measured: from enrolment to the day after the ablation procedure
Secondary outcomes (1)
Acute HRV variation (Hybrid vs. RF-only arm)
The secondary endpoint is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the Hybrid arm and the control arm (RF-only)
Measured: from enrolment to the day after the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start29 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VZW Cardiovascular Research Center Aalst
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Tom De Potter, MD, Principal investigator, Cardiovascular Research Center Aalst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647485
- Sponsor's protocol ID
- GPfIRE01-BWI-CS-012
- Other IDs
- CIV-24-02-046139-RS01
- Acronym
- GPfIRE
- Status last verified
- Jul 2025
- First submitted
- 15 Oct 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06647485
- Acronym / sponsor ID
- GPfIRE / GPfIRE01-BWI-CS-012
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF
- Keywords
- vagal modulation, ganglionated plexi, pulsed field, dual-energy focal ablation, paroxysmal atrial fibrillation, heart rate variability, pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- VZW Cardiovascular Research Center AalstUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Oct 2024 (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.
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-only | Experimental | Procedure: PF-only PVIThe PF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only PF energy |
| Hybrid (PF posterior/RF anterior) | Experimental | Procedure: Hybrid PVIThe Hybrid arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using both PF and RF energy |
| RF-only | Active comparator | Procedure: RF-only PVIThe RF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only RF energy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
- Age range: 18-70 years
- Willing and capable of providing informed consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (10 listed)
- Previously diagnosed Persistent AF (\> 7 days in duration)
- Previous LA ablation
- Previous cardiac surgery
- Myocardial Infarction within the previous 3 months
- Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
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 |
|---|---|---|
| PF-only PVIIt consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only PF energy for ablation | Procedure or surgery | PF-only |
| Hybrid PVIIt consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing both PF and RF energy for ablation. Specifically, PF energy is used for the posterior segments and RF energy for the anterior segments of the pulmonary veins | Procedure or surgery | Hybrid (PF posterior/RF anterior) |
| RF-only PVIIt consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only RF energy for ablation | Procedure or surgery | RF-only |
Primary outcome
Acute HRV variation (PF-only vs. RF-only arm)
Time frame: from enrolment to the day after the ablation procedure
It is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the PF-only arm and the control arm (RF-only).
1 secondary outcome
Acute HRV variation (Hybrid vs. RF-only arm)
Time frame: from enrolment to the day after the ablation procedure
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 10 Jul 2025.
- 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.
Tom De Potter, MD principal investigator
Cardiovascular Research Center Aalst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PF-only PVI, Hybrid PVI and RF-only PVI in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by VZW Cardiovascular Research Center Aalst at 1 site in Belgium.
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 4 inclusion and 10 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 10 Jul 2025. 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 Belgium. 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 Chiara Valeriano, MD (+34 697539354, chiara.valeriano91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute HRV variation (PF-only vs. RF-only arm) (time frame: from enrolment to the day after the ablation procedure). 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 10 Jul 2025.