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NCT Number: NCT05534581

SINGLE SHOT CHAMPION

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Number of participants with complications

    Time frame: Days 0 to 30 post-ablation

    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

  2. Total procedure time

    Time frame: Day 0

    Procedural endpoint

  3. Total left atrium indwelling time

    Time frame: Day 0

    Procedural endpoint

  4. Total fluoroscopy time

    Time frame: day 0

    Procedural endpoint

  5. Total radiation dose

    Time frame: Day 0

    Procedural endpoint

  6. Contrast agent usage

    Time frame: Day 0

    Procedural endpoint

  7. Increase in hsTroponin on day 1 post-ablation

    Time frame: Day 1

    Procedural endpoint

  8. Proportion of isolated veins

    Time frame: Day 0

    Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group

  9. Proportion of isolated carinas

    Time frame: Day 0

    Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group

  10. Lesion size

    Time frame: Day 0

    Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group

  11. Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation

    Time frame: Days 1 to 90 post-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).

  12. 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

    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

  13. Arrhythmia being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias)

    Time frame: 3, 12, 24 and 36 months follow up

    Comparison of the prevalence of the type of arrhythmia recurrences during follow-up being AF or organized atrial arrhythmias (AFL or AT)

  14. Average heart rates

    Time frame: Months 1, 2 and 3 post-ablation

    Average heart rates in ICM documentation in months 1, 2 and 3 after ablation

  15. 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)

    Based on telephone follow-up

  16. 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)

    Based on telephone follow-up

  17. 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)

    Based on telephone follow-up

  18. Reinitiation of antiarrhythmic drugs during follow-up

    Time frame: Months 3, 12, 24 and 36 post-ablation

    Reinitiation of antiarrhythmic drugs during follow-up based on telephone follow-up

  19. Number of reconnected veins evaluated during redo-procedures

    Time frame: During redo-procedure, expected to be on average 20-60 minutes

  20. Evolution of Quality of Life through months 3 and 12

    Time frame: Months 3 and 12 post-ablation

    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

  21. Stroke including TIA after 3, 12, 24 and 36 months

    Time frame: Months 3, 12, 24 and 36 post-ablation

  22. Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months

    Time frame: Months 3, 12, 24 and 36 post-ablation

  23. 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

  24. 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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