Paroxysmal AFVARIFYNCT07236619
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
A study testing Pulmonary vein isolation with the VariPulse catheter in people with Paroxysmal AF, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal AF
- What is being tested?
- Pulmonary vein isolation with the VariPulse catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Sep 2025to May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of symptomatic paroxysmal AF
- Participants who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF
- Participants who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedure
- Participants whose age is 18-80 years.
- Participants who are willing and capable of providing informed consent.
Who cannot join
- Any known contraindication to an AF ablation or anticoagulation
- History of previous LA ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Significant structural heart disease
- History of blood clotting or bleeding disease
- Severe kidney disease (glomerular filtration rate <30 ml/min/1.73 m2)
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- Stroke or transient ischemic attack <3 months prior to enrollment
- Active systemic infection
- Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study
- Participants who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation: a Prospective Remapping Study
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.
Read the detailed description
Rationale: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Pulmonary vein reconnection is associated with recurrence of arrhythmia, thus, durable PVI during the index procedure is important. Recently, pulsed field ablation (PFA) has emerged as a novel nonthermal energy source with high procedural safety and efficacy for PVI. Irreversible electroporation is achieved by the delivery of rapid, high-voltage pulsed electrical fields. Considering differences in catheter design and PFA protocols, it is important to establish PVI durability of the different PFA platforms. In the VARIFY study we will analyze PVI durability of the VARIPULSE platform in patients with paroxysmal AF using a 2-3 months protocol-mandated remapping study regardless of arrhythmia recurrence. Currently, there are no data on PVI durability of the VARIPULSE platform using mandatory remapping. Objective: To assess PVI durability in patients with paroxysmal AF who undergo a firsttime PVI with the VARIPULSE platform. Study design: Prospective, single-center study. Study population: Twenty consecutive adult patients (≥18 years old) with paroxysmal AF who are scheduled to undergo PVI with the VARIPULSE platform. Intervention: Patients will undergo a second invasive procedure 2-3 months after the index PVI. During the second procedure PVI durability will be assessed using high-definition mapping. Any reconnection will be targeted to achieve complete PVI. Main study parameters/endpoints: The primary outcome is the incidence of PV reconnection at the repeat procedure. The secondary outcome include the area of low voltage in the left atrium at the repeat procedure. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: All patients will undergo a repeat invasive procedure. This second procedure is associated with a similar procedural risk as the first procedure. A potential benefit of a mandated repeat procedure is that early pulmonary vein reconnection is identified and treated. Early treatment of pulmonary vein reconnection is associated with a better arrhythmia outcome.
- Conditions
- Paroxysmal AF
- Being tested
- Pulmonary vein isolation with the VariPulse catheter
- Keywords
- Varipulse, Catheter ablation, Atrial fibrillation, Paroxysmal atrial fibrillation, 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.
Pulmonary vein isolation with the VariPulse catheterDevice
Pulmonary vein isolation with the VariPulse catheter
| Study group | Role | What they receive |
|---|---|---|
| VariPulse treatment group | Experimental | Patients with paroxysmal AF undergoing treatment with the VariPulse catheter Receives: Device: Pulmonary vein isolation with the VariPulse catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pulmonary veins which shows reconnection during the repeat procedure 2-3 months after the index procedure
During the repeat procedure (2-3 months after the index procedure) the number of pulmonary veins which shows reconnection will be determined. The primary outcome measure is the percentage of pulmonary veins with reconnection.
Measured: PV reconnection will be determined in the period from 2 to 3 months after the index procedure.
Secondary outcomes (2)
One-year freedom from atrial arrhythmia after a blanking period of 3 months.
Recurrence of any atrial arrhythmia will be defined as the documentation of atrial arrhythmia on a standard 12-lead ECG or the documentation of ≥30 seconds of atrial arrhythmia on a Holter after a blanking period of 3 months. Twenty-four Holter monitoring will be performed at 6 and 12 months after the ablation procedure.
Measured: From 3 to 12 months after the index procedure.
Number of patients with a procedure-related complication
All procedure-related complications will be identified from the index procedure till the 1-year follow-up visit.
Measured: From the index procedure till the 1-year follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start27 Sep 2025
- Primary completion17 Aug 2026
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal AFStudies of the same condition, open and under way.
- More trials run by Erasmus 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Sing-Chien Yap, MD, PhD, Erasmus Medical Center
- Investigators
- Sing-Chien Yap, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236619
- Sponsor's protocol ID
- NL-010058
- Acronym
- VARIFY
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2025
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation: a Prospective Remapping Study
- ClinicalTrials.gov ID
- NCT07236619
- Acronym / sponsor ID
- VARIFY / NL-010058
- Conditions
- Paroxysmal AF
- Keywords
- Varipulse, Catheter ablation, Atrial fibrillation, Paroxysmal atrial fibrillation, Pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 27 Sep 2025 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Nov 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.
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.
Detailed description
Rationale: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Pulmonary vein reconnection is associated with recurrence of arrhythmia, thus, durable PVI during the index procedure is important. Recently, pulsed field ablation (PFA) has emerged as a novel nonthermal energy source with high procedural safety and efficacy for PVI. Irreversible electroporation is achieved by the delivery of rapid, high-voltage pulsed electrical fields. Considering differences in catheter design and PFA protocols, it is important to establish PVI durability of the different PFA platforms. In the VARIFY study we will analyze PVI durability of the VARIPULSE platform in patients with paroxysmal AF using a 2-3 months protocol-mandated remapping study regardless of arrhythmia recurrence. Currently, there are no data on PVI durability of the VARIPULSE platform using mandatory remapping. Objective: To assess PVI durability in patients with paroxysmal AF who undergo a firsttime PVI with the VARIPULSE platform. Study design: Prospective, single-center study. Study population: Twenty consecutive adult patients (≥18 years old) with paroxysmal AF who are scheduled to undergo PVI with the VARIPULSE platform. Intervention: Patients will undergo a second invasive procedure 2-3 months after the index PVI. During the second procedure PVI durability will be assessed using high-definition mapping. Any reconnection will be targeted to achieve complete PVI. Main study parameters/endpoints: The primary outcome is the incidence of PV reconnection at the repeat procedure. The secondary outcome include the area of low voltage in the left atrium at the repeat procedure. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: All patients will undergo a repeat invasive procedure. This second procedure is associated with a similar procedural risk as the first procedure. A potential benefit of a mandated repeat procedure is that early pulmonary vein reconnection is identified and treated. Early treatment of pulmonary vein reconnection is associated with a better arrhythmia outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VariPulse treatment group | Experimental | Device: Pulmonary vein isolation with the VariPulse catheterPatients with paroxysmal AF undergoing treatment with the VariPulse catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of symptomatic paroxysmal AF
- Participants who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF
- Participants who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedure
- Participants whose age is 18-80 years.
- Participants who are willing and capable of providing informed consent.
Key exclusion criteria (10 listed)
- Any known contraindication to an AF ablation or anticoagulation
- History of previous LA ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Significant structural heart disease
- History of blood clotting or bleeding disease
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 |
|---|---|---|
| Pulmonary vein isolation with the VariPulse catheterPulmonary vein isolation with the VariPulse catheter | Device | VariPulse treatment group |
Primary outcome
Percentage of pulmonary veins which shows reconnection during the repeat procedure 2-3 months after the index procedure
Time frame: PV reconnection will be determined in the period from 2 to 3 months after the index procedure.
During the repeat procedure (2-3 months after the index procedure) the number of pulmonary veins which shows reconnection will be determined. The primary outcome measure is the percentage of pulmonary veins with reconnection.
2 secondary outcomes
One-year freedom from atrial arrhythmia after a blanking period of 3 months.
Time frame: From 3 to 12 months after the index procedure.
Number of patients with a procedure-related complication
Time frame: From the index procedure till the 1-year follow-up visit.
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 11 Sep 2026.
- 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. This study is not recruiting at the moment.
Sing-Chien Yap, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation with the VariPulse catheter in people with Paroxysmal AF, run by Erasmus Medical Center at 1 site in Netherlands.
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 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 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 Netherlands. 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?
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?
Percentage of pulmonary veins which shows reconnection during the repeat procedure 2-3 months after the index procedure (time frame: PV reconnection will be determined in the period from 2 to 3 months after the index 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 11 Sep 2026.