CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 769 enrolled
Drug / intervention
Electrical isolation of the pulmonary veins +1 moreprocedure
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/NCT01490814
NCT01490814N/ACompleted
CompareCT.gov

A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF

Medtronic Cardiac Ablation Solutions·interventional·Posted Dec 13, 2011·Updated Apr 13, 2026

In Brief

A clinical study evaluating Electrical isolation of the pulmonary veins and Electrical isolation of pulmonary veins for Symptomatic Paroxysmal Atrial Fibrillation (PAF). Completed, enrolled 769 participants across 19 sites in 8 countries.

Detailed Summary

Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Paroxysmal Atrial Fibrillation (PAF)
CountriesCzechia, France, Germany, Hungary, Italy, Netherlands, Spain, Switzerland
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2011
Enrollment StartDec 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.6 years ago

Interventions

Electrical isolation of the pulmonary veinsprocedure

Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Electrical isolation of pulmonary veinsprocedure

Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.