How long pulmonary vein isolation lasts after VARIPULSE pulsed field ablation
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation: a Prospective Remapping Study
This project will test if the VARIPULSE pulsed field catheter keeps pulmonary veins electrically isolated two to three months after ablation in adults with paroxysmal atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT07236619 on ClinicalTrials.gov |
What this trial studies
The VARIFY protocol enrolls 20 adults with symptomatic paroxysmal atrial fibrillation who undergo pulmonary vein isolation (PVI) using the VARIPULSE pulsed field ablation (PFA) catheter at a single center. All participants will have a mandatory invasive remapping procedure 2–3 months after the index ablation using high-definition mapping to document vein isolation, and any reconnections found will be treated immediately. The trial emphasizes objective measurement of PVI durability for this specific PFA catheter rather than relying on clinical recurrence alone. Procedural metrics and safety events will also be captured to contextualize durability findings.
Who should consider this trial
Good fit: Adults aged 18–80 with symptomatic paroxysmal AF who are eligible for first-time PVI and willing to undergo a mandatory repeat invasive remapping procedure 2–3 months later.
Not a fit: Patients with prior left atrial ablation or surgery, significant structural heart disease, reversible causes of AF, severe kidney disease, recent stroke, bleeding or clotting disorders, active systemic infection, pregnancy, or any contraindication to ablation or anticoagulation are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could demonstrate more durable PVI with less collateral tissue damage than thermal methods, potentially reducing AF recurrence and the need for repeat procedures.
How similar studies have performed: Other pulsed field ablation platforms have shown promising safety and efficacy in recent studies, but there are limited published data specifically on VARIPULSE durability using protocol-mandated remapping.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1) History of symptomatic paroxysmal AF; 2) Participants who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF; 3) Participants who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedure; 4) Participants whose age is 18-80 years. 5) Participants who are willing and capable of providing informed consent. Exclusion Criteria: 1) Any known contraindication to an AF ablation or anticoagulation; 2) History of previous LA ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia; 3) AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause; 4) Significant structural heart disease; 5) History of blood clotting or bleeding disease; 6) Severe kidney disease (glomerular filtration rate \<30 ml/min/1.73 m2); 7) Stroke or transient ischemic attack \<3 months prior to enrollment; 8) Active systemic infection; 9) Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study; 10) Participants who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Sing-Chien Yap, MD, PhD — Erasmus Medical Center
- Study coordinator: Sing-Chien Yap, MD, PhD
- Email: s.c.yap@erasmusmc.nl
- Phone: +31650031551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.