Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
- Conditions
- Atrial FibrillationAtrial Fibrillation (Paroxysmal)
- Registration Number
- NCT06698159
- Lead Sponsor
- Hospital Universitario 12 de Octubre
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 440
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recurrence of atrial tachyarrhythmia From enrollment to the end of follow up, assessed up to 12 months Presence of atrial fibrillation, atrial flutter, atrial tachycardia in which the atrial rate exceeds 180 beats per minute, lasting more than 30 seconds after the blanking period (8 weeks) and without pharmacological anti-arrhythmic treatment during 12 months of follow-up with continuous ECG monitoring (in patients with continuous implantable monitor) or combined (in patients without implantable monitor), by optical heart rate monitoring combined with programmed intermittent ECG and in response to detection of heart rate irregularity).
Arrhythmic load From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient Total duration of the longest episode of atrial tachyarrhythmia for each patient (cut off point: 60 minutes)
- Secondary Outcome Measures
Name Time Method Acute effectiveness Every measure is assessed through procedure time, an average of 180 minutes * Total procedure duration
* Left atrial dwell time
* Radiation exposure (fluoroscopy time and dose-area product)
* Time to pulmonary vein electrical isolationEffectiveness in follow-up Until the end of the study * Cardiovascular admissions
* Visit to the emergency room for cardiovascular conditions
* Death from any cause / death from cardiovascular cause
* stroke/transient ischaemic attack
* Percentage of patients requiring electrical or pharmacological cardioversion or new ablation for atrial tachyarrhythmia.
* Percentage of patients with recurrence of AF after the blanking period and without pharmacological antiarrhythmic treatment.
* Time to first recurrence of atrial tachyarrhythmia
* Improvement in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) score from visit 0 (pre-ablation) to follow-up visit 12 months after ablation.Safety Until the end of the study * Major (death, complication requiring surgical or interventional treatment (vascular, coronary, cardiac, others) or prolongation of hospital stay \>48 hours, or complication with chronic sequelae or requiring chronic treatment for its management) and minor adverse events
* Intra-procedural complication rate
Trial Locations
- Locations (17)
IRCCS Neuromed Mediterranean Neurological Institute
🇮🇹Pozzilli, Isernia, Italy
Casa di cura Villa dei Fiori
🇮🇹Acerra, Napoli, Italy
Poliambulanza Institute Hospital Foundation
🇮🇹Brescia, Italy
Ospedale Santa Maria Goretti
🇮🇹Latina, Italy
Clinica San Michele
🇮🇹Maddaloni, Italy
Fondazione IRCCS San Gerardo dei Tintori
🇮🇹Monza, Italy
Pellegrini Hospital
🇮🇹Napoli, Italy
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
🇮🇹Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
🇮🇹Rome, Italy
S. Pietro Fatebenefratelli Hospital
🇮🇹Rome, Italy
HU Basurto
🇪🇸Bilbao, Spain
HU Virgen de las Nieves
🇪🇸Granada, Spain
HU Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
HU Ramón y Cajal
🇪🇸Madrid, Spain
HU Virgen de la Victoria
🇪🇸Málaga, Spain
HU Virgen Macarena
🇪🇸Sevilla, Spain