NCT00326001

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_4

Geographic Reach
3 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

February 18, 2010

Status Verified

August 1, 2009

Enrollment Period

3.8 years

First QC Date

May 12, 2006

Results QC Date

May 13, 2009

Last Update Submit

February 3, 2010

Conditions

Atrial Flutter

Keywords

Transvenous Catheter AblationRadiofrequency Catheter AblationAtrial flutterCatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • Duration of Energy Application

    Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.

    ablation procedure

Secondary Outcomes (3)

  • Ablation Success With the First Catheter

    ablation procedure

  • Number of Patients With Long-term Treatment Success

    6 months after ablation

  • Number of Patients With Charred Catheter Tips

    ablation procedure

Study Arms (2)

Gold tip catheter

EXPERIMENTAL

Gold tip catheter

Device: Gold tip catheter

Platinum-iridium tip catheter

ACTIVE COMPARATOR

Platinum-iridium tip catheter

Device: Platinum-iridium tip catheter

Interventions

Gold tip catheterDEVICE

Radiofrquency ablation using gold tip catheter

Gold tip catheter
Platinum-iridium tip catheterDEVICE

Radiofrequency ablation using platinum-iridium tip catheter

Platinum-iridium tip catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least one electrocardiogram (ECG)-documented (can be older than 3 months), symptomatic, typical atrial flutter episode with either negative, sawtooth-shaped P-waves in leads II, III, and augmented voltage foot (aVF), or positive P-waves in leads II, III, and aVF
  • At least one persistent, typical atrial flutter episode of over 2 hours that has been documented in the history in the patient file and/or ECG
  • Signed informed consent form

You may not qualify if:

  • Patient has recently undergone isthmus ablation
  • Acute coronary syndrome or myocardial infarction within the last 3 months
  • Acute reversible causes for atrial flutter (e.g. acute myocarditis)
  • Severe cardiac valvular defects
  • Tricuspid valve replacement
  • Atrial septum defect
  • Cardiovascular surgery scheduled within the next 6 months
  • New York Heart Association (NYHA) class IV
  • Women who are breastfeeding
  • Pregnancy
  • Abuse of drugs or alcohol
  • Patient is unable to participate in follow-up examinations
  • The patient has only partial legal competence
  • Participation in another clinical study
  • The ablation procedure presents an above average risk to the patient as compared to the normal patient group (must be noted by the physician on the appropriate form).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Institute of Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Universitätsklinik der RWTH Aachen

Aachen, 52074, Germany

Location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin

Berlin, 10117, Germany

Location

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

Universitätsklinikum Charité, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik

Berlin, 13125, Germany

Location

Universitätsklinikum Charité, Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik

Bochum, 44789, Germany

Location

Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn

Bonn, 53105, Germany

Location

Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser

Bremen, 28277, Germany

Location

Herzzentrum Duisburg

Duisburg, 47137, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location

Georg-August-Universität, Universitätsklinikum Göttingen

Göttingen, 37099, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Allgemeines Krankenhaus Altona

Hamburg, 22763, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätskliniken des Saarlandes

Homburg/Saar, 66421, Germany

Location

St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III

Karlsruhe, 76137, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Universitätsklinikum Mainz

Mainz, 55131, Germany

Location

Städtisches Krankenhaus München-Bogenhausen

München, 81925, Germany

Location

Universitätsklinikum Ulm

Ulm, 89070, Germany

Location

Klinikum der Stadt Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78050, Germany

Location

Medizinische Universitätsklinik Würzburg

Würzburg, 97080, Germany

Location

Semmelweis Medical University - Department of Cardiology

Budapest, 1122, Hungary

Location

The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology

Debrecen, 4032, Hungary

Location

The University of Pecs

Pécs, 7624, Hungary

Location

Related Publications (4)

  • Lewalter T, Bitzen A, Wurtz S, Blum R, Schlodder K, Yang A, Lickfett L, Schwab JO, Schrickel JW, Tiemann K, Linhart M, Zima E, Merkely B, Luderitz B. Gold-tip electrodes--a new "deep lesion" technology for catheter ablation? In vitro comparison of a gold alloy versus platinum-iridium tip electrode ablation catheter. J Cardiovasc Electrophysiol. 2005 Jul;16(7):770-2. doi: 10.1111/j.1540-8167.2005.40832.x.

    PMID: 16050836BACKGROUND

  • Berjano EJ. Gold-tip electrodes--a new 'deep lesion' technology for catheter ablation? In vitro comparison of gold alloy versus platinum-iridium tip electrode ablation catheter. J Cardiovasc Electrophysiol. 2005 Dec;16(12):1395-6. doi: 10.1111/j.1540-8167.2005.280_2.x. No abstract available.

    PMID: 16403084BACKGROUND

  • Lickfett L, Mittmann-Braun E, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Leyen JV, Mewis C, Bauer W, Lewalter T. Differences in clinical and echocardiographic parameters between paroxysmal and persistent atrial flutter in the AURUM 8 study: targets for prevention of persistent arrhythmia? Pacing Clin Electrophysiol. 2013 Feb;36(2):194-202. doi: 10.1111/pace.12051.

    PMID: 23379836DERIVED

  • Lewalter T, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Mittmann-Braun E, Lickfett L, Hoffmeister S, Proff J, Mewis C, Bauer W; AURUM 8 Study Investigators. Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study. Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28.

    PMID: 20876601DERIVED

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dejan Danilovic
Organization
Biotronik GmbH&Co. KG, Berlin, Germany
dejan.danilovic@biotronik.com
+49 9131 8924 7832

Study Officials

  • Thorsten Lewalter, Assoc. Prof. Dr.

    Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

June 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 18, 2010

Results First Posted

February 4, 2010

Record last verified: 2009-08

Locations

HU(3)CZ(1)DE(24)