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Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

NCT01056328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2019-02-26

Study results available
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Summary

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

SJM Irrigated Cardiac Ablation System

Irrigated ablation catheter

DEVICE

FDA approved Open Irrigated RF Ablation System

Irrigated ablation catheter

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States
  • Canada
  • South Korea

Study Locations

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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 NCT01056328 on ClinicalTrials.gov