Clinical trial NCT06698159: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
Keywords: atrial fibrilation
cryoballoon
cryoablation
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The distribution of patients to each arm will be in a 1:1 ratio.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Recurrence of atrial tachyarrhythmia
timeFrame: From enrollment to the end of follow up, assessed up to 12 months
measure: Arrhythmic load
timeFrame: From enrollment to the end of follow up, assessed up to 12 months
measure: Arrhythmic load
timeFrame: From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient
Secondary outcomes:
measure: Acute effectiveness
timeFrame: Every measure is assessed through procedure time, an average of 180 minutes
measure: Effectiveness in follow-up
timeFrame: Until the end of the study
measure: Safety
timeFrame: Until the end of the study
measure: Acute effectiveness
timeFrame: Every measure is assessed through procedure time, an average of 180 minutes
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed Mediterranean Neurological Institute
state: Isernia
city: Acerra
country: Italy
facility: Casa di cura Villa dei Fiori
state: Napoli
city: Brescia
country: Italy
facility: Poliambulanza Institute Hospital Foundation
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Maddaloni
country: Italy
facility: Clinica San Michele
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Napoli
country: Italy
facility: Pellegrini Hospital
city: Padova
country: Italy
facility: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
city: Rome
country: Italy
facility: S. Pietro Fatebenefratelli Hospital
city: Bilbao
country: Spain
facility: HU Basurto
city: Granada
country: Spain
facility: HU Virgen de las Nieves
city: Huelva
country: Spain
facility: HU Juan Ramón Jiménez
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: HU Ramón y Cajal
city: Málaga
country: Spain
facility: HU Virgen de la Victoria
city: Sevilla
country: Spain
facility: HU Virgen Macarena
Study officials:
References: