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Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

NCT01408485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-02-15

Study results available
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Summary

To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

Conditions

  • Typical Atrial Flutter

Interventions

DEVICE

Therapy™ Cool Flex™ Irrigated Ablation System

The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Raul Weiss, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • United States
  • Canada

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 NCT01408485 on ClinicalTrials.gov