Paroxysmal Atrial FibrillationPhase 4NCT05534581
SINGLE SHOT CHAMPION
A Phase 4 study testing PVI using the Arctic Front Cryoballoon (Medtronic) and PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific) in people with Paroxysmal Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- PVI using the Arctic Front Cryoballoon (Medtronic) and PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 26 Sep 2022to Jan 2027
- Phase
- Phase 4
- 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
- Paroxysmal atrial fibrillation documented on a 12 lead ECG or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any AF that converts to sinus rhythm within 7 days either spontaneously or by pharmacological or electrical cardioversion
- Candidate for ablation based on current AF guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a novel oral anticoagulant for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or computer tomography that excludes left atrial (LA) thrombus ≤48 hours before ablation
- Age of 18 years or older on the date of consent
- Informed Consent as documented by signature
Who cannot join
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- Intracardiac thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
Show all 25Show fewer
- Prior mitral valve surgery
- Severe mitral regurgitation or moderate/severe mitral stenosis
- Myocardial infarction during the 3-month period preceding the consent date
- Ongoing triple therapy
- Cardiac surgery during the three-month interval preceding the consent date or scheduled cardiac surgery/TAVI procedure
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) <35%
- Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
- Significant chronic kidney disease (CKD; eGFR <30 ml/min)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the consent date
- Ongoing systemic infections
- History of cryoglobulinemia
- Cardiac amyloidosis
- Pregnancy
- Life expectancy less than one (1) year per physician opinion
- Currently participating in any other clinical trial, which may confound the results of this trial.
- Unwilling or unable to comply fully with study procedures and follow-up.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel
Basel, 4031
Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Single Shot Pulmonary Vein Isolation: Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation - A Multi-Center Non-Inferiority Design Clinical Trial (The SINGLE SHOT CHAMPION Trial)
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel method, pulse-field ablation (PFA) using the FARAPULSE catheter, has recently been introduced (FARAPULSE PFA, Boston Scientific). However, whether FARAPULSE PFA provides effectiveness similar to the standard-of-practice Medtronic Arctic Front Cryoballoon is yet to be investigated. Given that FARAPULSE PFA has shown in studies not to cause any of the severe complications reported in association with traditional PVI while being highly effective, it might be even safer and more effective for use in AF ablation procedures.
The aim of this trial is to compare the efficacy and safety of PVI using FARAPULSE PFA (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI.
Read more
This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for PVI and the FARAPULSE PFA is the novel technology, this trial has a non-inferiority design.
The null hypothesis with regards to the primary efficacy endpoint is that the FARAPULSE PFA (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence, the alternative hypothesis postulates that the FARAPULSE PFA is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- PVI using the Arctic Front Cryoballoon (Medtronic), PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)
- Keywords
- Pulmonary vein isolation, Cryoballoon, Pulsed field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI using the Arctic Front Cryoballoon (Medtronic)Device
Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.
PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)Device
Patients randomized to the Pulsed Field Ablation group will undergo PVI using the FARAPULSE PFA system (Boston Scientific). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Arctic Front Cryoballoon (Medtronic) | Active comparator | Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic) Receives: Device: PVI using the Arctic Front Cryoballoon (Medtronic) |
| Pulsed Field Ablation (FARAPULSE) | Active comparator | Pulmonary vein isolation using the FARAPULSE PFA system (Boston Scientific) Receives: Device: PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recurrence of any atrial tachyarrhythmia
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).
Measured: Days 91 to 365 post-ablation
Secondary outcomes (24)
Number of participants with complications
Composite safety endpoint composed of:
- cardiac tamponade requiring drainage
- persistent phrenic nerve palsy lasting >24 hours
- serious vascular complications requiring intervention
- stroke/TIA
- atrioesophageal fistula
- death
Measured: Days 0 to 30 post-ablation
Total procedure time
Procedural endpoint
Measured: Day 0
Total left atrium indwelling time
Procedural endpoint
Measured: Day 0
Total fluoroscopy time
Procedural endpoint
Measured: day 0
Total radiation dose
Procedural endpoint
Measured: Day 0
Contrast agent usage
Procedural endpoint
Measured: Day 0
Increase in hsTroponin on day 1 post-ablation
Procedural endpoint
Measured: Day 1
Proportion of isolated veins
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Measured: Day 0
Proportion of isolated carinas
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Measured: Day 0
Lesion size
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Measured: Day 0
Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 1 and 90 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).
Measured: Days 1 to 90 post-ablation
Arrhythmia burden evaluated based on continuous ICM (overall AF burden = % time in AF)
Assessed by the ICM Core Lab post implantation: between 0-90 days; 91-365 days, 365 days to explantation/end of life of the ICM
Measured: Between: 0-90 days, 91-365 days, 365 days up to 3.5 years
Arrhythmia being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias)
Comparison of the prevalence of the type of arrhythmia recurrences during follow-up being AF or organized atrial arrhythmias (AFL or AT)
Measured: 3, 12, 24 and 36 months follow up
Average heart rates
Average heart rates in ICM documentation in months 1, 2 and 3 after ablation
Measured: Months 1, 2 and 3 post-ablation
Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias
Based on telephone follow-up
Measured: Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias
Based on telephone follow-up
Measured: Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias
Based on telephone follow-up
Measured: Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Reinitiation of antiarrhythmic drugs during follow-up
Reinitiation of antiarrhythmic drugs during follow-up based on telephone follow-up
Measured: Months 3, 12, 24 and 36 post-ablation
Number of reconnected veins evaluated during redo-procedures
Measured: During redo-procedure, expected to be on average 20-60 minutes
Evolution of Quality of Life through months 3 and 12
QoL questionnaires (EQ-5D) will be sent to the patients by mail after 3 and 12 months to compare the evolution of QoL after the ablation
Measured: Months 3 and 12 post-ablation
Stroke including TIA after 3, 12, 24 and 36 months
Measured: Months 3, 12, 24 and 36 post-ablation
Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months
Measured: Months 3, 12, 24 and 36 post-ablation
Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres
Measured: During redo-procedure, expected to be on average 20-60 minutes
Size (area calculate in cm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres
Measured: During redo-procedure, expected to be on average 20-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start26 Sep 2022
- Primary completion1 Jan 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Tobias Reichlin, MD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534581
- Sponsor's protocol ID
- 2022-D0024
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.
PubMed 31085321Reichlin T, Kueffer T, Badertscher P, Juni P, Knecht S, Thalmann G, Kozhuharov N, Krisai P, Jufer C, Maurhofer J, Heg D, Pereira TV, Mahfoud F, Servatius H, Tanner H, Kuhne M, Roten L, Sticherling C; SINGLE SHOT CHAMPION Investigators. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025 Apr 17;392(15):1497-1507. doi: 10.1056/NEJMoa2502280. Epub 2025 Mar 31.
PubMed 40162734
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Shot Pulmonary Vein Isolation: Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation - A Multi-Center Non-Inferiority Design Clinical Trial (The SINGLE SHOT CHAMPION Trial)
- ClinicalTrials.gov ID
- NCT05534581
- Acronym / sponsor ID
- 2022-D0024
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Pulmonary vein isolation, Cryoballoon, Pulsed field ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Sep 2022 (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.
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel method, pulse-field ablation (PFA) using the FARAPULSE catheter, has recently been introduced (FARAPULSE PFA, Boston Scientific). However, whether FARAPULSE PFA provides effectiveness similar to the standard-of-practice Medtronic Arctic Front Cryoballoon is yet to be investigated. Given that FARAPULSE PFA has shown in studies not to cause any of the severe complications reported in association with traditional PVI while being highly effective, it might be even safer and more effective for use in AF ablation procedures.
The aim of this trial is to compare the efficacy and safety of PVI using FARAPULSE PFA (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI.
This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for PVI and the FARAPULSE PFA is the novel technology, this trial has a non-inferiority design.
The null hypothesis with regards to the primary efficacy endpoint is that the FARAPULSE PFA (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence, the alternative hypothesis postulates that the FARAPULSE PFA is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arctic Front Cryoballoon (Medtronic) | Active comparator | Device: PVI using the Arctic Front Cryoballoon (Medtronic)Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic) |
| Pulsed Field Ablation (FARAPULSE) | Active comparator | Device: PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)Pulmonary vein isolation using the FARAPULSE PFA system (Boston Scientific) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Paroxysmal atrial fibrillation documented on a 12 lead ECG or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any AF that converts to sinus rhythm within 7 days either spontaneously or by pharmacological or electrical cardioversion
- Candidate for ablation based on current AF guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a novel oral anticoagulant for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or computer tomography that excludes left atrial (LA) thrombus ≤48 hours before ablation
- Age of 18 years or older on the date of consent
- Informed Consent as documented by signature
Key exclusion criteria (25 listed)
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- Intracardiac thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
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 |
|---|---|---|
| PVI using the Arctic Front Cryoballoon (Medtronic)Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring. | Device | Arctic Front Cryoballoon (Medtronic) |
| PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)Patients randomized to the Pulsed Field Ablation group will undergo PVI using the FARAPULSE PFA system (Boston Scientific). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring. | Device | Pulsed Field Ablation (FARAPULSE) |
Primary outcome
Time to first recurrence of any atrial tachyarrhythmia
Time frame: Days 91 to 365 post-ablation
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).
24 secondary outcomes
Number of participants with complications
Time frame: Days 0 to 30 post-ablation
Total procedure time
Time frame: Day 0
Total left atrium indwelling time
Time frame: Day 0
Total fluoroscopy time
Time frame: day 0
Total radiation dose
Time frame: Day 0
Contrast agent usage
Time frame: Day 0
Increase in hsTroponin on day 1 post-ablation
Time frame: Day 1
Proportion of isolated veins
Time frame: Day 0
Proportion of isolated carinas
Time frame: Day 0
Lesion size
Time frame: Day 0
Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation
Time frame: Days 1 to 90 post-ablation
Arrhythmia burden evaluated based on continuous ICM (overall AF burden = % time in AF)
Time frame: Between: 0-90 days, 91-365 days, 365 days up to 3.5 years
Arrhythmia being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias)
Time frame: 3, 12, 24 and 36 months follow up
Average heart rates
Time frame: Months 1, 2 and 3 post-ablation
Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias
Time frame: Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias
Time frame: Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias
Time frame: Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Reinitiation of antiarrhythmic drugs during follow-up
Time frame: Months 3, 12, 24 and 36 post-ablation
Number of reconnected veins evaluated during redo-procedures
Time frame: During redo-procedure, expected to be on average 20-60 minutes
Evolution of Quality of Life through months 3 and 12
Time frame: Months 3 and 12 post-ablation
Stroke including TIA after 3, 12, 24 and 36 months
Time frame: Months 3, 12, 24 and 36 post-ablation
Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months
Time frame: Months 3, 12, 24 and 36 post-ablation
Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres
Time frame: During redo-procedure, expected to be on average 20-60 minutes
Size (area calculate in cm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres
Time frame: During redo-procedure, expected to be on average 20-60 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 27 Mar 2026.
- Background: PubMed 31085321Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.
- Derived from this study: PubMed 40162734Reichlin T, Kueffer T, Badertscher P, Juni P, Knecht S, Thalmann G, Kozhuharov N, Krisai P, Jufer C, Maurhofer J, Heg D, Pereira TV, Mahfoud F, Servatius H, Tanner H, Kuhne M, Roten L, Sticherling C; SINGLE SHOT CHAMPION Investigators. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025 Apr 17;392(15):1497-1507. doi: 10.1056/NEJMoa2502280. Epub 2025 Mar 31.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Tobias Reichlin, MD principal investigator
Inselspital, Bern University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PVI using the Arctic Front Cryoballoon (Medtronic) and PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific) in people with Paroxysmal Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 5 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrence of any atrial tachyarrhythmia (time frame: Days 91 to 365 post-ablation). 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 NCT05534581, which also lists 2 linked publications.
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 27 Mar 2026.