MedTrace Logo

Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

NCT01116557 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

Conditions

Interventions

DEVICE

Radiofrequency Ablation procedure

Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.

DEVICE

Radiofrequency Ablation procedure

Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Mattias Duytschaever, MD · A.Z. St Jan AV

  • Yves De Greef, MD · A.Z. Middelheim

  • Stuart Harris, MD · Essex Cardiothoracic Centre

  • Peter Steen Hansen, MD · Heart Center Varde

  • Pepijn Van Der Voort, MD · Catharina Ziekenhuis

  • Thomas Deneke, MD · Krankenhaus Porz Cologne

  • Atul Verma, MD · Southlake Regional Health Centre

  • Arif Elvan, MD · Isala

  • Yaariv Khaykin, MD · Southlake Regional Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

More Related Trials

Entities

Diseases

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 NCT01116557 on ClinicalTrials.gov