Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF

Фаза 4 Завершено NCT04704986

Кратко

Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI. Currently, Medtronic Arctic Front cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel cryoballoon technology has recently been introduced (PolarX, Boston Scientific). However, whether PolarX provides effectiveness similar to the standard-of-practice Medtronic Arctic Front cryoballoon is yet to be investigated. Given that PolarX was developed considering the reported limitations and potential failures associated with the Medtronic Arctic Front cryoballoon, it might be even more effective and safe for use in AF ablation procedures. The aim of this trial is to compare the efficacy and safety of the PolarX Cryoballoon (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 single shot PVI and the P

Number of Patients With Recurrence of Any Atrial Tachyarrhythmia

days 91 to 365 post-ablation · Participants

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

• Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coord — Weill Medical College of Cornell University
• Amplatzer Amulet China Post Market Study (PMS) — Abbott Medical Devices
• Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmia — Oxford University Hospitals NHS Trust
• Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation — Massachusetts General Hospital
• Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With N — Intermountain Health Care, Inc.
• Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintai — Ottawa Heart Institute Research Corporation

Все исследования