CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
Boston Scientific Cardiac Cryoablation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04250714
NCT04250714N/ACompleted
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POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

Boston Scientific Corporation·observational·Posted Jan 31, 2020·Updated Apr 4, 2025

In Brief

An observational study evaluating Boston Scientific Cardiac Cryoablation System for Atrial Fibrillation. Completed, enrolled 400 participants across 19 sites in 7 countries.

Detailed Summary

This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBelgium, Croatia, France, Germany, Italy, Netherlands, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 31, 2020
Enrollment StartAug 6, 2020
Primary CompletionSep 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.4 years ago

Interventions

Boston Scientific Cardiac Cryoablation Systemdevice

cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins