NCT06698159Recruiting
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial
Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 1 May 2026
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Diseases
- Atrial fibrillation
- NCT number
- NCT06698159
What you commit to
- Study type: Interventional
- Planned participants: 440
- From 1 Nov 2024 to the primary completion date, 1 May 2026
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous endocardial or surgical ablation of atrial fibrillation.
Other illness
- Severe mitral or aortic valve disease.
- Congenital heart disease.
Other
- Severe left atrial dilatation (indexed volume \>48 ml/m2 or area \>40 cm2 or indexed diameter \>3.0 cm/m2).
- 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.
- Pregnancy or the prospect of pregnancy in the next 12 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hu Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Not yet recruiting |
| HU Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| HU Juan Ramón Jiménez Coordinator of this site? Confirm its status | Huelva | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| HU Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| HU Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| HU Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Not yet recruiting |
| Casa di cura Villa dei Fiori Coordinator of this site? Confirm its status | Acerra | Italy | Not yet recruiting |
| Poliambulanza Institute Hospital Foundation Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Ospedale Santa Maria Goretti Coordinator of this site? Confirm its status | Latina | Italy | Not yet recruiting |
| Clinica San Michele Coordinator of this site? Confirm its status | Maddaloni | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| Pellegrini Hospital Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| IRCCS Neuromed Mediterranean Neurological Institute Coordinator of this site? Confirm its status | Pozzilli | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore" Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| S. Pietro Fatebenefratelli Hospital Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
Related publications
- 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 · PMID 41196540
This page is information, not medical advice. Discuss any trial with your doctor.