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

NCT06698159 | Recruiting DMC

• 1 other identifier: WIDER-PVI
• Study Type: interventional
• Target: 440
• Locations: 2 countries
• Sites: 17

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.

Conditions

Atrial Fibrillation; Atrial Fibrillation (Paroxysmal)

Keywords

atrial fibrilation; cryoballoon; cryoablation

Outcome Measures

Primary Outcomes (3)

• Recurrence of atrial tachyarrhythmia

  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).

  From enrollment to the end of follow up, assessed up to 12 months

• Arrhythmic load

  Percentage of time the patient has atrial tachyarrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia in which the atrial rate exceeds 180 beats per minute) over the total monitored time.

  From enrollment to the end of follow up, assessed up to 12 months

• Arrhythmic load

  Total duration of the longest episode of atrial tachyarrhythmia for each patient (cut off point: 60 minutes)

  From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient

Secondary Outcomes (4)

• Acute effectiveness

  Every measure is assessed through procedure time, an average of 180 minutes

• Effectiveness in follow-up

  Until the end of the study

• Safety

  Until the end of the study

• Acute effectiveness

  Every measure is assessed through procedure time, an average of 180 minutes

Study Arms (2)

Control strategy

ACTIVE COMPARATOR

Pulmonary vein isolation by 28 mm balloon cryoablation

Device: Cryoablation with cryoballoon 28 mm

Experimental strategy

EXPERIMENTAL

Pulmonary vein isolation by 31 mm balloon cryoablation

Device: Cryoablation with cryoballoon 31 mm

Interventions

Cryoablation with cryoballoon 28 mm DEVICE

Pulmonary vein isolation using 28 mm balloon cryoablation

Control strategy

Cryoablation with cryoballoon 31 mm DEVICE

Pulmonary vein isolation using 31 mm balloon cryoablation

Experimental strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (17)

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

Napoli, Italy

NOT YET RECRUITING

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

Padua, 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

Related Publications (1)

• 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-PVI trial. J Interv Card Electrophysiol. 2026 Jan;69(1):153-162. doi: 10.1007/s10840-025-02173-x. Epub 2025 Nov 6.

  PMID: 41196540 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Daniel Rodríguez Muñoz, MD PhD

CONTACT

659385591; daniel.rodriguez.mnz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operators will not be blinded and will be aware of patient randomisation, which is necessary for the performance of the ablation procedure. The patient participant and the recurrence evaluation committee will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The distribution of patients to each arm will be in a 1:1 ratio.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 20, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

IT (10); ES (7)