SINGLE SHOT CHAMPION

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Sep 7, 2022

Keywords

ClinConnect Summary

The SINGLE SHOT CHAMPION trial is studying two different treatments for a heart condition called paroxysmal atrial fibrillation (AF), which causes an irregular heartbeat. The trial is comparing a widely used treatment called the Arctic Front Cryoballoon to a new method called FARAPULSE PFA. Researchers want to find out if the newer treatment is just as effective and safe as the standard one. The trial will include patients who have been diagnosed with paroxysmal AF and are planning to undergo their first procedure to help correct it.

To be eligible, participants must be at least 18 years old and have had documented episodes of AF in the last two years. They should also be on blood-thinning medication for at least four weeks before the procedure. People with certain heart conditions, prior surgeries, or other serious health issues may not be able to participate. If enrolled, participants can expect to receive one of the two treatments and will be monitored for their heart rhythm recovery over the course of a year. This trial is important because it could help determine if the new FARAPULSE treatment is a safe and effective option for patients with AF.

Gender

ALL

Eligibility criteria

• 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.