SINGLE SHOT CHAMPION

Insel Gruppe AG, University Hospital Bern

Status and phase: Active, not recruiting; Phase 4

Conditions: Paroxysmal Atrial Fibrillation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05534581

2022-D0024

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Arctic Front Cryoballoon (Medtronic)

Active Comparator group

Description:

Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)

Treatment:

Device: PVI using the Arctic Front Cryoballoon (Medtronic)

Pulsed Field Ablation (FARAPULSE)

Active Comparator group

Description:

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

Treatment:

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