Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Cryoablation, Pressure waveforms
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.
Interventions
PROCEDUREcryoablation 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.
Sponsors
Boston Scientific Corporation
Hospital Universitario 12 de Octubre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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) |
| Radiation dose | 1 day | Mean radiation required for pulmonary vein isolation (Gycm2) |
| 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) |
Countries
Spain
Contacts
Primary ContactAdolfo Fontenla, MD, PhD
Outcome results
None listed