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Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

NCT01687166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2018-11-21

Study results available
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Summary

The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

Conditions

  • Paroxysmal Atrial Fibrillation (PAF)

Interventions

DEVICE

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

DEVICE

FDA Approved Open-Irrigated Ablation Catheter

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, M.D. · Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States
  • Australia
  • Czechia
  • France
  • Germany
  • Portugal
  • Spain
  • Sweden
  • 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 NCT01687166 on ClinicalTrials.gov