Comparing two cryoablation techniques for treating atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The WIDER-PVI study is a multicenter randomized clinical trial designed to compare the efficacy of two cryoablation techniques for pulmonary vein isolation in patients with paroxysmal or persistent atrial fibrillation. Participants will undergo either antral isolation using a 28 mm cryoballoon or extended antral isolation using a 31 mm cryoballoon. The primary objective is to determine if the extended antral isolation technique results in lower recurrence rates of atrial tachyarrhythmias at one year follow-up. This study aims to provide insights into the effectiveness of newer, larger cryoablation devices in improving patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario 12 de Octubre
  Madrid, Spain Recruiting
• 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

Study contacts

• Study coordinator: Daniel Rodríguez Muñoz, MD PhD
• Email: daniel.rodriguez.mnz@gmail.com
• Phone: 659385591

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF

  This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07893821

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

• 4D intracardiac echocardiography to guide left atrial appendage occlusion procedures

  A new 4D ICE catheter is being tested alongside standard imaging to see if it can safely guide left atrial appendage occlusion procedures for adults with atrial fibrillation.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07806890

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.