Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)

Official title

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

Overview

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.

Detailed description

Ablation has become a first-line therapy in the rhythm control strategy for atrial fibrillation (AF).

Pulmonary vein electrical isolation (PVI) is the cornerstone of ablation therapy, based on its efficacy profile, safety and lack of alternatives.

Single shot techniques have been increasingly used as the initial approach for PVI, employing cryoablation, i.e. release of cryoenergy into the endocardium via an inflatable catheter, to achieve isolation.

The most commonly used diameter in cryoablation is 28 mm. These generate antral isolation whose profile depends on the distance between veins. When the application is made with larger devices, as has been observed with the cryoballoon with an expandable diameter of 31 mm or ablation devices using pulsed electric fields, the isolation is also antral at the level of the carina, making the result of PVI more similar to that obtained when ablation is performed with a Wide Antral Circumferential Ablation (WACA) strategy using point-to-point radiofrequency (the gold standard for PVI).

The WIDER-PVI study aims to answer the question of whether single-shot ablation with a 31 mm diameter device is superior to conventional ablation with a 28 mm diameter device. The answer to this question is relevant in the context of the development of new, larger devices and concerns about the impact of larger ablation on atrial function.

Interventions

• Device Cryoablation with cryoballoon 28 mm
  Pulmonary vein isolation using 28 mm balloon cryoablation
• Device Cryoablation with cryoballoon 31 mm
  Pulmonary vein isolation using 31 mm balloon cryoablation

Primary outcome measures

• Recurrence of atrial tachyarrhythmia [Time frame: From enrollment to the end of follow up, assessed up to 12 months]
• Arrhythmic load [Time frame: From enrollment to the end of follow up, assessed up to 12 months]
• Arrhythmic load [Time frame: From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient]

Secondary outcome measures (4)

• Acute effectiveness [Time frame: Every measure is assessed through procedure time, an average of 180 minutes]
• Effectiveness in follow-up [Time frame: Until the end of the study]
• Safety [Time frame: Until the end of the study]
• Acute effectiveness [Time frame: Every measure is assessed through procedure time, an average of 180 minutes]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Italy · 10 centers

• IRCCS Neuromed Mediterranean Neurological Institute — Pozzilli
• Casa di cura Villa dei Fiori — Acerra
• Poliambulanza Institute Hospital Foundation — Brescia
• Ospedale Santa Maria Goretti — Latina
• Clinica San Michele — Maddaloni
• Fondazione IRCCS San Gerardo dei Tintori — Monza
• Pellegrini Hospital — Naples
• Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova — Padova
• … and 2 more centers

Spain · 7 centers

• HU Basurto — Bilbao
• HU Virgen de las Nieves — Granada
• HU Juan Ramón Jiménez — Huelva
• Hospital Universitario 12 de Octubre — Madrid
• HU Ramón y Cajal — Madrid
• HU Virgen de la Victoria — Málaga
• HU Virgen Macarena — Seville

Publications

• Cobarro L, Negreira-Caamano M, Gomez-Burgueno L, Lopez-Alacid I, Ramos-Jimenez J, Marco Del Castillo A, Rajjoub Al-Mahdi EA, Borrego-Bernabe L, Estevez-Paniagua A, Boveda S, Delgado J, Salguero-Bodes R, Arribas-Ynsaurriaga F, Rodriguez-Munoz D. Wide-Antral pulmonary vein isolation in patients undergoing atrial fibrillation ablation with a Single-Shot technique: rationale and design of the WIDER-PV PMID 41196540

Identifiers

NCT: NCT06698159 · WIDER-PVI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗