MedTrace Logo

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

NCT00984204 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2019-02-19

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Conditions

  • Typical Atrial Flutter

Interventions

DEVICE

Therapy Cool Path Duo

All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2012-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT00984204 on ClinicalTrials.gov