Clinical trial NCT05603091: Pressure Wave Guided Atrial Fibrillation Cryoablation
Official title: Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Cryoablation
Pressure waveforms
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2022-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of patients who are candidates for paroxysmal or persistent AF ablation, in accordance with the conventional indications of the technique according to current European clinical practice guidelines

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival
timeFrame: 12 months
Secondary outcomes:
measure: Successfully completed ablation procedures
timeFrame: 12 months
measure: Symptoms associated with atrial fibrillation
timeFrame: 12 months
measure: Safety events
timeFrame: 30 days
measure: Acute results of pressure guided cryoablation procedures (global and for each vein)
timeFrame: 1 day
measure: Performance of pressure guided cryoablation procedures
timeFrame: 1 day
measure: Temperature parameters obtained during pressure guided cryoablation procedures (global and for each vein)
timeFrame: 1 day
measure: Time parameters obtained during pressure guided cryoablation
timeFrame: 1 day
measure: Radiation dose
timeFrame: 1 day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre, Madrid. Spain
name: Adolfo Fontenla, MD, PhD
role: STUDY_CHAIR
References:
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