Comparison of two ablation methods for the sclerotherapy treatment of recurrent atrial fibrillation

Switzerland (ICTRP)

ICTRP Studien-ID
NCT05534581 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
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) (BASEC)

Wissenschaftlicher Titel
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) (ICTRP)

Öffentlicher Titel
SINGLE SHOT CHAMPION (ICTRP)

Untersuchte Krankheit(en)
Paroxysmal Atrial Fibrillation (ICTRP)

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

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
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. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Time to first recurrence of any atrial tachyarrhythmia (ICTRP)

Number of participants with complications;Total procedure time;Total left atrium indwelling time;Total fluoroscopy time;Total radiation dose;Contrast agent usage;Increase in hsTroponin on day 1 post-ablation;Proportion of isolated veins;Proportion of isolated carinas;Lesion size;Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation;Arrhythmia burden evaluated based on continuous ICM (overall AF burden = % time in AF);Arrhythmia being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias);Average heart rates;Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias;Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias;Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias;Reinitiation of antiarrhythmic drugs during follow-up;Number of reconnected veins evaluated during redo-procedures;Evolution of Quality of Life through months 3 and 12;Stroke including TIA after 3, 12, 24 and 36 months;Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months;Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres;Size (area calculate in cm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
University of Bern (ICTRP)

Weitere Kontakte
Tobias Reichlin, MD, Inselspital, Bern University Hospital (ICTRP)

Sekundäre IDs
2022-D0024 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05534581 (ICTRP)