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NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

NCT00964392 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2025-02-04

Study results available
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Summary

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

Atrial fibrillation ablation

Radiofrequency ablation

Sponsors & Collaborators

  • Biosense Webster, Inc.

    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
2009-09-01
Primary Completion
2013-09-01
Completion
2018-01-05

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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 NCT00964392 on ClinicalTrials.gov