CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 458 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/NCT04133168
NCT04133168N/ACompleted
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Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Boston Scientific Corporation·interventional·Posted Oct 21, 2019·Updated Apr 3, 2025

In Brief

A clinical study evaluating Boston Scientific Cardiac Cryoablation System for Paroxysmal Atrial Fibrillation. Completed, enrolled 458 participants across 44 sites in 9 countries.

Detailed Summary

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesBelgium, Canada, France, Germany, Hong Kong, Italy, Netherlands, Taiwan, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 21, 2019
Enrollment StartJun 24, 2020
Primary CompletionNov 10, 2022
Study CompletionAug 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.7 years ago

Interventions

Boston Scientific Cardiac Cryoablation Systemdevice

The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx™ FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories