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Studies

Interventional Active not recruiting Phase 4

NCT05534581 on ClinicalTrials.gov

SINGLE SHOT CHAMPION

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)

  • Sponsor: University Hospital of Bern
  • Collaborators: University of Bern
  • Enrollment: 210 (Actual)
  • Study start: 2022-09-26 (Actual)
  • Primary completion: 2025-01-01 (Actual)
  • Study completion: 2027-01-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Device: PVI using the Arctic Front Cryoballoon (Medtronic)
  • Device: PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)

Primary Outcome Measures

  • Time to first recurrence of any atrial tachyarrhythmia (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).

Countries

Switzerland

Locations and Investigators

  • University Hospital Basel, Basel, Switzerland
  • Inselspital, Bern University Hospital, Bern, Switzerland

Study Officials

  • Tobias Reichlin, MD (Principal Investigator) — Inselspital, Bern University Hospital