CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Arctic Front 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/NCT00889681
NCT00889681N/ACompleted
CompareCT.gov

CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Apr 29, 2009·Updated Sep 19, 2018

In Brief

A clinical study evaluating Arctic Front Cardiac Cryoablation System for Atrial Fibrillation. Completed, enrolled 81 participants across 10 sites.

Detailed Summary

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.2 years ago

Interventions

Arctic Front Cardiac Cryoablation Systemdevice

The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.