Pressure Wave Guided Atrial Fibrillation Cryoablation (POLAR-WAVE)

Madrid Health Service

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: cryoablation of pulmonary veins

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05603091

POLAR-WAVE

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years.
• Paroxysmal, persistent, or long-lasting persistent atrial fibrillation.
• Indication of pulmonary vein ablation according to clinical practice guidelines.

Exclusion criteria

• Previous ablation of atrial fibrillation.
• Thrombus in the left atrium.
• Rheumatic heart disease.
• Hypertrophic cardiomyopathy.
• Absolute contraindication to anticoagulation.
• Women in a state of pregnancy, lactation or childbearing age without contraception.
• Life expectancy < 1 year.

Trial design

100 participants in 1 patient group

Pressure guided cryoablation

Description:

Patients undergoing cryoablation of atrial fibrillation with catheter-balloon, where the evaluation of the pulmonary veins occlusion will be assessed by the analysis of the pressure waveforms obtained from the tip of the catheter (without injecting contrast).

Treatment:

Procedure: cryoablation of pulmonary veins