NCT05603091

Pressure Wave Guided Atrial Fibrillation Cryoablation

Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective multicenter observational study evaluating the performance of pressure wave-guided atrial fibrillation cryoablation used in accordance with clinical practice guidelines.

Detailed description

The POLAR-WAVE registry is a prospective, multi-center, single-arm study evaluating the efficacy and safety of pressure-guided atrial fibrillation cryoablation, where the occlusion of pulmonary veins will be assessed by pressure waveforms (instead of contrast), over a follow-up period of 12 months. This is a non-commercial, investigator-driven clinical study, coordinated by the main investigator from University Hospital "12th of October", Madrid, Spain. Several responsibilities are delegated to the Clinical Research Unit (University Hospital "12th of October", Madrid, Spain). The study was planned according to the Good Clinical Practices. POLAR-WAVE Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	cryoablation of pulmonary veins	Procedures are guided by pressure waveforms analysis, which are obtained by connecting the internal lumen of the catheter through the lateral port of the hemostatic valve attached to the catheter, to a pressure transducer connected in turn to a heparinized saline serum bag and to the cryoablation console.

Timeline

• Start date: 2022-10-19
• Primary completion: 2024-03-31
• Completion: 2024-06-30
• First posted: 2022-11-02
• Last updated: 2023-01-31

Locations

1 site across 1 country: Spain