Comparing two cryoablation techniques for treating atrial fibrillation

Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial

This study is testing whether a larger cryoablation technique can help people with atrial fibrillation have fewer heart rhythm problems after treatment compared to a smaller technique.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Universitario 12 de Octubre (other)
• Locations: 17 sites (Pozzilli, Isernia and 16 other locations)
• Trial ID: NCT06698159 on ClinicalTrials.gov

What this trial studies

The WIDER-PVI study is a multicenter randomized clinical trial designed to compare the efficacy of two cryoablation techniques for pulmonary vein isolation in patients with paroxysmal or persistent atrial fibrillation. Participants will undergo either antral isolation using a 28 mm cryoballoon or extended antral isolation using a 31 mm cryoballoon. The primary objective is to determine if the extended antral isolation technique results in lower recurrence rates of atrial tachyarrhythmias at one year follow-up. This study aims to provide insights into the effectiveness of newer, larger cryoablation devices in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with a recent diagnosis of paroxysmal or persistent atrial fibrillation who require pulmonary vein isolation.

Not a fit: Patients with severe left atrial dilatation, previous ablation procedures, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with atrial fibrillation, potentially reducing the recurrence of arrhythmias.

How similar studies have performed: Previous studies have shown promising results with cryoablation techniques, but this specific comparison of antral versus extended antral isolation is novel.

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.

Where this trial is running

Pozzilli, Isernia and 16 other locations

• IRCCS Neuromed Mediterranean Neurological Institute — Pozzilli, Isernia, Italy (NOT_YET_RECRUITING)
• Casa di cura Villa dei Fiori — Acerra, Napoli, Italy (NOT_YET_RECRUITING)
• Poliambulanza Institute Hospital Foundation — Brescia, Italy (NOT_YET_RECRUITING)
• Ospedale Santa Maria Goretti — Latina, Italy (NOT_YET_RECRUITING)
• Clinica San Michele — Maddaloni, Italy (NOT_YET_RECRUITING)
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Italy (NOT_YET_RECRUITING)
• Pellegrini Hospital — Naples, Italy (NOT_YET_RECRUITING)
• Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova — Padova, Italy (NOT_YET_RECRUITING)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore" — Rome, Italy (NOT_YET_RECRUITING)
• S. Pietro Fatebenefratelli Hospital — Rome, Italy (NOT_YET_RECRUITING)
• HU Basurto — Bilbao, Spain (NOT_YET_RECRUITING)
• HU Virgen de las Nieves — Granada, Spain (NOT_YET_RECRUITING)
• HU Juan Ramón Jiménez — Huelva, Spain (NOT_YET_RECRUITING)
• Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
• HU Ramón y Cajal — Madrid, Spain (NOT_YET_RECRUITING)
• HU Virgen de la Victoria — Málaga, Spain (NOT_YET_RECRUITING)
• HU Virgen Macarena — Seville, Spain (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Daniel Rodríguez Muñoz, MD PhD

Conditions: Atrial Fibrillation, atrial fibrilation, cryoballoon, cryoablation