Pressure Wave Guided Atrial Fibrillation Cryoablation

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: cryoablation of pulmonary veins

• Registration Number: NCT05603091
• Lead Sponsor: Hospital Universitario 12 de Octubre

Brief 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.

Study Timeline

• Study Start: 2022-10-19
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-11-02
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pressure guided cryoablation	cryoablation of pulmonary veins	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).

Primary Outcome Measures

Name	Time	Method
Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival	12 months	Proportion of patients without AT/AF episodes (excluding a window period of 3 months from ablation)

Secondary Outcome Measures

Name	Time	Method
Temperature parameters obtained during pressure guided cryoablation procedures (global and for each vein)	1 day	* Minimum temperature (degrees Celsius); * Temperature at 30 seconds (degrees Celsius); * Temperature at 60 seconds (degrees Celsius)
Performance of pressure guided cryoablation procedures	1 day	Total procedure time (min), dwell time in the left atrium (min), cryotherapy time (min), fluoroscopy time (min)
Symptoms associated with atrial fibrillation	12 months	European Heart Rhythm Association Symptom Scale (I-IV). Higher scores mean a worse outcome.
Safety events	30 days	Proportion of serious and non-serious procedure related events
Radiation dose	1 day	Mean radiation required for pulmonary vein isolation (Gycm2)
Acute results of pressure guided cryoablation procedures (global and for each vein)	1 day	proportion of isolated veins, proportion of isolated veins with single application.
Successfully completed ablation procedures	12 months	Proportion of pulmonary vein isolation (PVI) procedures exclusively guided by pressure
Time parameters obtained during pressure guided cryoablation	1 day	* Time up to -40 degrees Celsius (sec); * Time up to -50 degrees Celsius (sec); * Defrosting time up to 0 degrees Celsius (sec); * Defrosting time up to +15 degrees Celsius (sec)

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain