Pressure Wave Guided Atrial Fibrillation Cryoablation

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

Detailed Description
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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.

Official Title
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Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: cryoablation of pulmonary veins


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pressure guided cryoablation<br>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). | Procedure: cryoablation of pulmonary veins<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival | Proportion of patients without AT/AF episodes (excluding a window period of 3 months from ablation) | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Cryoablation, Pressure waveforms