Atrial FibrillationWIDER-PVINCT06698159
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
A study testing Cryoablation with cryoballoon 28 mm and Cryoablation with cryoballoon 31 mm in people with Atrial Fibrillation and Atrial Fibrillation (Paroxysmal), run by Hospital Universitario 12 de Octubre at 17 sites in 2 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation (Paroxysmal)
- What is being tested?
- Cryoablation with cryoballoon 28 mm and Cryoablation with cryoballoon 31 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 1 Nov 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
Italy10 sites, 10 recruiting
- Not yet recruiting
Casa di cura Villa dei Fiori
Acerra, Napoli
- Not yet recruiting
Poliambulanza Institute Hospital Foundation
Brescia
- Not yet recruiting
Ospedale Santa Maria Goretti
Latina
- Not yet recruiting
Clinica San Michele
Maddaloni
- Not yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza
- Not yet recruiting
Pellegrini Hospital
Naples
- Not yet recruiting
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
Padova
- Not yet recruiting
IRCCS Neuromed Mediterranean Neurological Institute
Pozzilli, Isernia
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
Rome
- Not yet recruiting
S. Pietro Fatebenefratelli Hospital
Rome
Spain7 sites, 7 recruiting
- Not yet recruiting
HU Basurto
Bilbao
- Not yet recruiting
HU Virgen de las Nieves
Granada
- Not yet recruiting
HU Juan Ramón Jiménez
Huelva
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Daniel Rodríguez Muñoz
- Not yet recruiting
HU Ramón y Cajal
Madrid
- Not yet recruiting
HU Virgen de la Victoria
Málaga
- Not yet recruiting
HU Virgen Macarena
Seville
About this study
Official title: 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.
Read the 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.
- Being tested
- Cryoablation with cryoballoon 28 mm, Cryoablation with cryoballoon 31 mm
- Keywords
- atrial fibrilation, cryoballoon, cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation with cryoballoon 28 mmDevice
Pulmonary vein isolation using 28 mm balloon cryoablation
Cryoablation with cryoballoon 31 mmDevice
Pulmonary vein isolation using 31 mm balloon cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Control strategy | Active comparator | Pulmonary vein isolation by 28 mm balloon cryoablation Receives: Device: Cryoablation with cryoballoon 28 mm |
| Experimental strategy | Experimental | Pulmonary vein isolation by 31 mm balloon cryoablation Receives: Device: Cryoablation with cryoballoon 31 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
Measured: From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient
Secondary outcomes (4)
Acute effectiveness
- 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
Measured: Every measure is assessed through procedure time, an average of 180 minutes
Effectiveness in follow-up
- 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.
Measured: Until the end of the study
Safety
- 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
Measured: Until the end of the study
Acute effectiveness
- Total procedure duration
- Left atrial dwell time
- Radiation exposure (fluoroscopy time and dose-area product)
- Time to pulmonary vein electrical isolation
Measured: Every measure is assessed through procedure time, an average of 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Nov 2024
- Primary completion1 May 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The distribution of patients to each arm will be in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Rodríguez Muñoz, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698159
- Sponsor's protocol ID
- WIDER-PVI
- Acronym
- WIDER-PVI
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41196540
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial
- ClinicalTrials.gov ID
- NCT06698159
- Acronym / sponsor ID
- WIDER-PVI / WIDER-PVI
- Keywords
- atrial fibrilation, cryoballoon, cryoablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The distribution of patients to each arm will be in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Control strategy | Active comparator | Device: Cryoablation with cryoballoon 28 mmPulmonary vein isolation by 28 mm balloon cryoablation |
| Experimental strategy | Experimental | Device: Cryoablation with cryoballoon 31 mmPulmonary vein isolation by 31 mm balloon cryoablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation with cryoballoon 28 mmPulmonary vein isolation using 28 mm balloon cryoablation | Device | Control strategy |
| Cryoablation with cryoballoon 31 mmPulmonary vein isolation using 31 mm balloon cryoablation | Device | Experimental strategy |
Primary outcome
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).
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.
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)
4 secondary outcomes
Acute effectiveness
Time frame: Every measure is assessed through procedure time, an average of 180 minutes
Effectiveness in follow-up
Time frame: Until the end of the study
Safety
Time frame: Until the end of the study
Acute effectiveness
Time frame: Every measure is assessed through procedure time, an average of 180 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 41196540Cobarro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation with cryoballoon 28 mm and Cryoablation with cryoballoon 31 mm in people with Atrial Fibrillation and Atrial Fibrillation (Paroxysmal), run by Hospital Universitario 12 de Octubre at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Rodríguez Muñoz, MD PhD (659385591, daniel.rodriguez.mnz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial tachyarrhythmia (time frame: From enrollment to the end of follow up, assessed up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.