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Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)

NCT00326001 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2010-02-18

Study results available
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Summary

The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in patients with atrial flutter.

Conditions

  • Atrial Flutter

Interventions

DEVICE

Gold tip catheter

Radiofrquency ablation using gold tip catheter

DEVICE

Platinum-iridium tip catheter

Radiofrequency ablation using platinum-iridium tip catheter

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Thorsten Lewalter, Assoc. Prof. Dr. · Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Czechia
  • Germany
  • Hungary

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 NCT00326001 on ClinicalTrials.gov