Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
Recruiting · NCT07236619 · Interventional (participants receive a specific treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- 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 it is running
1 location listed.
- Erasmus MC - Rotterdam, South Holland, Netherlands