SINGLE SHOT CHAMPION

NCT05534581 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2022-D0024
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Pulmonary vein isolation; Cryoballoon; Pulsed field ablation

Outcome Measures

Primary Outcomes (1)

• 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).

  Days 91 to 365 post-ablation

Secondary Outcomes (24)

• Number of participants with complications

  Days 0 to 30 post-ablation

• Total procedure time

  Day 0

• Total left atrium indwelling time

  Day 0

• Total fluoroscopy time

  day 0

• Total radiation dose

  Day 0

Study Arms (2)

Arctic Front Cryoballoon (Medtronic)

ACTIVE COMPARATOR

Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)

Device: PVI using the Arctic Front Cryoballoon (Medtronic)

Pulsed Field Ablation (FARAPULSE)

ACTIVE COMPARATOR

Pulmonary vein isolation using the FARAPULSE PFA system (Boston Scientific)

Device: PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)

Interventions

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.

Arctic Front Cryoballoon (Medtronic)

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.

Pulsed Field Ablation (FARAPULSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (2)

University Hospital Basel

Basel, 4031, Switzerland

Location

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31085321 BACKGROUND

• Reichlin 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.

  PMID: 40162734 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias Reichlin, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 9, 2022
• Study Start: September 26, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)