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Continued Access Protocol

NCT00889681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2018-09-19

Study results available
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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.

Conditions

Interventions

DEVICE

Arctic Front Cardiac Cryoablation System

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Douglas Packer, MD · Mayo Clinic, Rochester, MN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889681 on ClinicalTrials.gov