NCT06698159 Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
| NCT ID | NCT06698159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario 12 de Octubre |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2024-11-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \>30 seconds duration and in overall arrhythmic load.
Eligibility Criteria
Inclusion Criteria: * Age over 18 years old. * Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 years after diagnosis. * Clinical indication to undergo a pulmonary vein isolation procedure using balloon cryoablation. Exclusion Criteria: * Severe left atrial dilatation (indexed volume \>48 ml/m2 or area \>40 cm2 or indexed diameter \>3.0 cm/m2). * Previous endocardial or surgical ablation of atrial fibrillation. * Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy less than 1 year. * Inability to understand or give informed consent. * Performance of other left atrial ablations in addition to pulmonary veins. * Need to use another catheter in addition to the cryoablation catheter to complete pulmonary vein isolation. * Contraindication to anticoagulation or intolerance to heparin. * Presence of intra-atrial thrombus. * Reversible cause of atrial fibrillation. * Severe mitral or aortic valve disease. * Congenital heart disease. * Pregnancy or the prospect of pregnancy in the next 12 months.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06698159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06698159 currently recruiting?
Yes, NCT06698159 is actively recruiting participants. Contact the research team at daniel.rodriguez.mnz@gmail.com for enrollment information.
Where is the NCT06698159 trial being conducted?
This trial is being conducted at Pozzilli, Italy, Acerra, Italy, Brescia, Italy, Latina, Italy and 11 additional locations.
Who is sponsoring the NCT06698159 clinical trial?
NCT06698159 is sponsored by Hospital Universitario 12 de Octubre. The trial plans to enroll 440 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.