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Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

NCT01185613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-04

No results posted yet for this study

Summary

The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Therapy™ Cool Flex Ablation Catheter

The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes. The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter * IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher. * Cool Point™ Irrigation Pump * Cool Point™ Tubing set * Data Logger

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Australia
  • France
  • Germany
  • Italy
  • Portugal
  • United Kingdom

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 NCT01185613 on ClinicalTrials.gov