Atrial Fibrillation (AF)VARI-POWERNCT07779369
Pulsed Field Ablation for Atrial Fibrillation Using the VARIPULSE™ Catheter
A study testing Pulsed Field Ablation (PFA) with the VARIPULSE™ catheter in people with Atrial Fibrillation (AF), run by Radboud University Medical Center.
Trial summary
Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulsed Field Ablation (PFA) with the VARIPULSE™ catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 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
- ≥18 years of age
- AF and eligible for index PVI according to current ESC guidelines
Who cannot join
- Unwilling or unable to give written informed consent
- Prior left atrial ablation
- Other left atrial arrhythmias including atrial flutters
- Prior left atrial surgery
- Severe mitral valve regurgitation
- Contraindication for gadolinium-based contrast agents
- Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)
- Renal insufficiency (eGFR < 30 ml/min)
About this study
Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury. Pulsed field ablation (PFA) offers a non-thermal, tissue-specific alternative that may provide more durable isolation while also reducing procedural risks. While early data for the CE-marked VARIPULSE™ PFA system are promising, long-term lesion durability remains mostly unquantified. To obtain a definitive estimate of PFA effectiveness, a systematic invasive re-mapping approach is required. Advanced cardiac magnetic resonance (CMR) imaging can quantify atrial fibrosis after PVI across different ablation modalities, but it is unknown how well these imaging findings correspond with invasive electrical mapping. In the current study, CMR serves as a complementary modality to explore whether imaging-based tissue changes align with invasively confirmed long-term isolation.
Objective: The primary objective is to evaluate the long-term durability of pulmonary vein isolation (PVI) using the VARIPULSE™ Pro PFA system, as defined by the rate of electrical reconnection during systematic invasive re-mapping at three months.
Read more
Study design: Prospective multicenter intervention study. Study population: Patients ≥ 18 years old, eligible for primary PVI according to ESC guidelines, without contraindications for gadolinium-based contrast-enhanced CMR imaging.
Intervention: Patients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections.
Main study parameters/endpoints: Primary outcome measure: Patient-level PV lesion durability. Secondary outcome measures: Percentage chronic isolation for each PV; Location of reconnection during re-map and lesion characteristics; Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure); Procedural fluoroscopy time and radiation dose; Percentage direct isolation for each pulmonary vein (PV); Acute PV reconnection for each PV; Percentage freedom from atrial achyarrhythmias at 12 months follow-up; Incidence of procedure related adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation involves standard PVI care with additional CMR imaging and an invasive re-map procedure. Early studies show that PFA with the VARIPULSE™ catheter is safe, and the extra imaging adds only minimal burden or risk. The re-map study carries the same risks as standard ablation. Overall, the study is expected to provide valuable insights that may further improve patient care and outcomes in atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulsed Field Ablation (PFA) with the VARIPULSE™ catheter
- Keywords
- Atrial Fibrillation, Pulsed Field Ablation, LGE-CMR
- 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) with the VARIPULSE™ catheterDevice
Pulsed field ablation (PFA) is a non-thermal catheter ablation technology that creates myocardial lesions through irreversible electroporation by delivering short, high-voltage electrical pulses. This mechanism preferentially affects cardiomyocytes while minimizing damage to adjacent structures such as the esophagus, phrenic nerve, and pulmonary veins.
The VARIPULSE™ catheter is a variable-loop, multielectrode, biphasic PFA catheter integrated with the CARTO® 3 electroanatomical mapping system. It is designed to perform pulmonary vein isolation by delivering pulsed electrical fields around the pulmonary vein ostia. In this study, the VARIPULSE™ catheter will be used for pulmonary vein isolation in patients with atrial fibrillation, followed by systematic invasive remapping to assess long-term pulmonary vein isolation durability and reconnection rates.
| Study group | Role | What they receive |
|---|---|---|
| Patients will undergo Pulmonary Vein Isolation (PVI) using Pulsed Field Ablation (PFA) | Other | Patients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections. Receives: Device: Pulsed Field Ablation (PFA) with the VARIPULSE™ catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level pulmonary vein lesion durability
Measured: Determined during invasive re-mapping, performed 3-4 months after pulmonary vein isolation (PVI)
Secondary outcomes (7)
PV reconnection for each PV, the location of PV reconnection, the lesion characteristics, and the re-intervention rate during the invasive re-map procedure
Measured: Determined during invasive re-mapping, performed 3-4 months post-PVI
Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure)
Measured: Within 72 hours post-PVI and after 3 months post-PVI
Procedural fluoroscopy time and radiation dose
Measured: During PVI procedure
Percentage direct isolation for each PV
Measured: During PVI procedure
Acute PV reconnection for each PV
Measured: PVI procedure
Percentage freedom from atrial tachyarrhythmias
Measured: At 3 months and 12 months follow-up
Incidence of procedure related adverse events
including: atrio-esophageal fistula, cardiac tamponade/perforation, death, embolic event, esophageal injury, major vascular access complication, myocardial infarction, pericarditis, phrenic nerve injury/diaphragmatic paralysis, pulmonary vein stenosis, stroke/transient ischemic attack.
Measured: During PVI procedure, and during re-map procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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.
- More trials run by Radboud University Medical CenterThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779369
- Sponsor's protocol ID
- NL-011250
- Acronym
- VARI-POWER
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified IPD will be available under restricted access after publication of the study results. Researchers may submit a request to the corresponding author, and data sharing will be considered in accordance with applicable ethical, legal, and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation for Atrial Fibrillation Using the VARIPULSE™ Catheter
- ClinicalTrials.gov ID
- NCT07779369
- Acronym / sponsor ID
- VARI-POWER / NL-011250
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Pulsed Field Ablation, LGE-CMR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Amsterdam UMC
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 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.
Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury. Pulsed field ablation (PFA) offers a non-thermal, tissue-specific alternative that may provide more durable isolation while also reducing procedural risks. While early data for the CE-marked VARIPULSE™ PFA system are promising, long-term lesion durability remains mostly unquantified. To obtain a definitive estimate of PFA effectiveness, a systematic invasive re-mapping approach is required. Advanced cardiac magnetic resonance (CMR) imaging can quantify atrial fibrosis after PVI across different ablation modalities, but it is unknown how well these imaging findings correspond with invasive electrical mapping. In the current study, CMR serves as a complementary modality to explore whether imaging-based tissue changes align with invasively confirmed long-term isolation.
Objective: The primary objective is to evaluate the long-term durability of pulmonary vein isolation (PVI) using the VARIPULSE™ Pro PFA system, as defined by the rate of electrical reconnection during systematic invasive re-mapping at three months.
Study design: Prospective multicenter intervention study. Study population: Patients ≥ 18 years old, eligible for primary PVI according to ESC guidelines, without contraindications for gadolinium-based contrast-enhanced CMR imaging.
Intervention: Patients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections.
Main study parameters/endpoints: Primary outcome measure: Patient-level PV lesion durability. Secondary outcome measures: Percentage chronic isolation for each PV; Location of reconnection during re-map and lesion characteristics; Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure); Procedural fluoroscopy time and radiation dose; Percentage direct isolation for each pulmonary vein (PV); Acute PV reconnection for each PV; Percentage freedom from atrial achyarrhythmias at 12 months follow-up; Incidence of procedure related adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation involves standard PVI care with additional CMR imaging and an invasive re-map procedure. Early studies show that PFA with the VARIPULSE™ catheter is safe, and the extra imaging adds only minimal burden or risk. The re-map study carries the same risks as standard ablation. Overall, the study is expected to provide valuable insights that may further improve patient care and outcomes in atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will undergo Pulmonary Vein Isolation (PVI) using Pulsed Field Ablation (PFA) | Other | Device: Pulsed Field Ablation (PFA) with the VARIPULSE™ catheterPatients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- AF and eligible for index PVI according to current ESC guidelines
Key exclusion criteria (8 listed)
- Unwilling or unable to give written informed consent
- Prior left atrial ablation
- Other left atrial arrhythmias including atrial flutters
- Prior left atrial surgery
- Severe mitral valve regurgitation
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) with the VARIPULSE™ catheterPulsed field ablation (PFA) is a non-thermal catheter ablation technology that creates myocardial lesions through irreversible electroporation by delivering short, high-voltage electrical pulses. This mechanism preferentially affects cardiomyocytes while minimizing damage to adjacent structures such as the esophagus, phrenic nerve, and pulmonary veins. The VARIPULSE™ catheter is a variable-loop, multielectrode, biphasic PFA catheter integrated with the CARTO® 3 electroanatomical mapping system. It is designed to perform pulmonary vein isolation by delivering pulsed electrical fields around the pulmonary vein ostia. In this study, the VARIPULSE™ catheter will be used for pulmonary vein isolation in patients with atrial fibrillation, followed by systematic invasive remapping to assess long-term pulmonary vein isolation durability and reconnection rates. | Device | Patients will undergo Pulmonary Vein Isolation (PVI) using Pulsed Field Ablation (PFA) |
Primary outcome
Patient-level pulmonary vein lesion durability
Time frame: Determined during invasive re-mapping, performed 3-4 months after pulmonary vein isolation (PVI)
7 secondary outcomes
PV reconnection for each PV, the location of PV reconnection, the lesion characteristics, and the re-intervention rate during the invasive re-map procedure
Time frame: Determined during invasive re-mapping, performed 3-4 months post-PVI
Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure)
Time frame: Within 72 hours post-PVI and after 3 months post-PVI
Procedural fluoroscopy time and radiation dose
Time frame: During PVI procedure
Percentage direct isolation for each PV
Time frame: During PVI procedure
Acute PV reconnection for each PV
Time frame: PVI procedure
Percentage freedom from atrial tachyarrhythmias
Time frame: At 3 months and 12 months follow-up
Incidence of procedure related adverse events
Time frame: During PVI procedure, and during re-map 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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided. De-identified IPD will be available under restricted access after publication of the study results. Researchers may submit a request to the corresponding author, and data sharing will be considered in accordance with applicable ethical, legal, and data protection requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation (PFA) with the VARIPULSE™ catheter in people with Atrial Fibrillation (AF), run by Radboud University Medical Center.
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 8 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient-level pulmonary vein lesion durability (time frame: Determined during invasive re-mapping, performed 3-4 months after pulmonary vein isolation (PVI)). 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 21 Aug 2026.