A randomized controlled trial of the size-adjustable cryoballoon vs conventional cryoballoon for paroxysmal atrial fibrillation: The CONTRAST-CRYO II trial rationale and design

Abstract

Background

Pulmonary vein isolation (PVI) with cryoballoon technology is a well-established therapy for treatment of atrial fibrillation (AF). Recently, a size-adjustable cryoballoon (POLARx^TM FIT) that enables delivery in a standard 28-mm or an expanded 31-mm size was introduced.

Objective

The purpose of this study was to perform a randomized clinical trial to evaluate the safety and efficacy of this novel cryoballoon compared to the conventional cryoballoon.

Methods

The CONTRAST-CRYO II trial is a multicenter, prospective, open-label, randomized controlled trial in which 214 patients with paroxysmal AF will be randomized 1:1 to cryoballoon ablation with either a conventional cryoballoon (Arctic Front Advance^TM Pro) or a size-adjustable cryoballoon (POLARx FIT). The study was approved by the Institutional Review Boards at all investigational sites and has been registered in the UMIN Clinical Trials Registry (UMIN000052500).

Results

The primary endpoint of this study will be the incidence of phrenic nerve injury. Secondary endpoints include procedural success, chronic success through 12 months, procedure-related adverse events, biophysiological parameters during applications for each pulmonary vein (PV), total procedural and fluoroscopy times, level of PVI and isolation area, and probability of non-PV foci initiating AF.

Conclusion

The CONTRAST-CRYO II trial is a multicenter, prospective, randomized controlled trial designed to assess the safety and efficacy of the POLARx FIT vs the Arctic Front Advance Pro. The findings from this trial will provide additional utility data on the efficacy of the size-adjustable cryoballoon for isolating PVs in patients with paroxysmal AF.