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

November 18, 2024 updated by: Daniel Rodríguez Muñoz, Hospital Universitario 12 de Octubre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Brescia, Italy
        • Not yet recruiting
        • Poliambulanza Institute Hospital Foundation
      • Latina, Italy
        • Not yet recruiting
        • Ospedale Santa Maria Goretti
      • Maddaloni, Italy
        • Not yet recruiting
        • Clinica San Michele
      • Monza, Italy
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
      • Napoli, Italy
        • Not yet recruiting
        • Pellegrini Hospital
      • Padova, Italy
        • Not yet recruiting
        • Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
      • Rome, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
      • Rome, Italy
        • Not yet recruiting
        • S. Pietro Fatebenefratelli Hospital
    • Isernia
      • Pozzilli, Isernia, Italy
        • Not yet recruiting
        • IRCCS Neuromed Mediterranean Neurological Institute
    • Napoli
      • Acerra, Napoli, Italy
        • Not yet recruiting
        • Casa di cura Villa dei Fiori
  • Spain
      • Bilbao, Spain
        • Not yet recruiting
        • HU Basurto
      • Granada, Spain
        • Not yet recruiting
        • HU Virgen de las Nieves
      • Huelva, Spain
        • Not yet recruiting
        • HU Juan Ramón Jiménez
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 De Octubre
        • Contact:
          • Daniel Rodríguez Muñoz
      • Madrid, Spain
        • Not yet recruiting
        • HU Ramón y Cajal
      • Málaga, Spain
        • Not yet recruiting
        • HU Virgen de la Victoria
      • Sevilla, Spain
        • Not yet recruiting
        • HU Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control strategy
Pulmonary vein isolation by 28 mm balloon cryoablation
Device: Cryoablation with cryoballoon 28 mm
Pulmonary vein isolation using 28 mm balloon cryoablation
Experimental: Experimental strategy
Pulmonary vein isolation by 31 mm balloon cryoablation
Device: Cryoablation with cryoballoon 31 mm
Pulmonary vein isolation using 31 mm balloon cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of atrial tachyarrhythmia
Time Frame: 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).
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
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
Time Frame: 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)
From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute effectiveness
Time Frame: Every measure is assessed through procedure time, an average of 180 minutes
  • Percentage of veins in which complete occlusion (grade 4) is achieved pre-application
  • Percentage of veins requiring change to other than randomly assigned diameter
  • Percentage of patients in whom time to electrical isolation is visualised
  • Percentage of patients in whom pulmonary vein isolation is achieved at first application
  • Percentage of patients with termination of AF during applications, transitioning to sinus rhythm or to atrial tachycardia or flutter
Every measure is assessed through procedure time, an average of 180 minutes
Effectiveness in follow-up
Time Frame: 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.
Until the end of the study
Safety
Time Frame: 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
Until the end of the study
Acute effectiveness
Time Frame: 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 isolation
Every measure is assessed through procedure time, an average of 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIDER-PVI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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