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

Last updated: November 18, 2024
Sponsor: Hospital Universitario 12 de Octubre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

Cryoablation with cryoballoon 31 mm

Cryoablation with cryoballoon 28 mm

Clinical Study ID

NCT06698159
WIDER-PVI
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age over 18 years old.

  • Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 yearsafter diagnosis.

  • Clinical indication to undergo a pulmonary vein isolation procedure using ballooncryoablation.

Exclusion

Exclusion Criteria:

  • Severe left atrial dilatation (indexed volume >48 ml/m2 or area >40 cm2 or indexeddiameter >3.0 cm/m2).

  • Previous endocardial or surgical ablation of atrial fibrillation.

  • Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy lessthan 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 completepulmonary 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.

Study Design

Total Participants: 440
Treatment Group(s): 2
Primary Treatment: Cryoablation with cryoballoon 31 mm
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • IRCCS Neuromed Mediterranean Neurological Institute

    Pozzilli, Isernia
    Italy

    Site Not Available

  • Casa di cura Villa dei Fiori

    Acerra, Napoli
    Italy

    Site Not Available

  • Poliambulanza Institute Hospital Foundation

    Brescia,
    Italy

    Site Not Available

  • Ospedale Santa Maria Goretti

    Latina,
    Italy

    Site Not Available

  • Clinica San Michele

    Maddaloni,
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza,
    Italy

    Site Not Available

  • Pellegrini Hospital

    Napoli,
    Italy

    Site Not Available

  • Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova

    Padova,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"

    Rome,
    Italy

    Site Not Available

  • S. Pietro Fatebenefratelli Hospital

    Rome,
    Italy

    Site Not Available

  • HU Basurto

    Bilbao,
    Spain

    Site Not Available

  • HU Virgen de las Nieves

    Granada,
    Spain

    Site Not Available

  • HU Juan Ramón Jiménez

    Huelva,
    Spain

    Site Not Available

  • HU Ramón y Cajal

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • HU Virgen de la Victoria

    Málaga,
    Spain

    Site Not Available

  • HU Virgen Macarena

    Sevilla,
    Spain

    Site Not Available

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