search
Back to results

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

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Gold tip catheter
Platinum-iridium tip catheter
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring Transvenous Catheter Ablation, Radiofrequency Catheter Ablation, Atrial flutter, Catheter Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Unstable medication in the last 7 days before study inclusion 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). Right atrial thrombus Late Exclusion Criteria: Patient included by accident Premature termination of the ablation procedure Atrial flutter not dependent on the posterior isthmus No conduction at the posterior isthmus before ablation

Sites / Locations

  • Institute of Clinical and Experimental Medicine
  • Universitätsklinik der RWTH Aachen
  • Kerckhoff Klinik
  • Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
  • Vivantes Klinikum Am Urban
  • Universitätsklinikum Charité, Campus Benjamin Franklin
  • Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik
  • Universitätsklinikum Charité, Campus Virchow-Klinikum
  • Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik
  • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn
  • Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser
  • Evangelisches Krankenhaus Düsseldorf
  • Herzzentrum Duisburg
  • Georg-August-Universität, Universitätsklinikum Göttingen
  • Universitätsklinikum Hamburg-Eppendorf
  • Allgemeines Krankenhaus Altona
  • Medizinische Hochschule Hannover
  • Universitätskliniken des Saarlandes
  • St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III
  • Herzzentrum Leipzig GmbH
  • Universitätsklinikum Mainz
  • Städtisches Krankenhaus München-Bogenhausen
  • Universitätsklinikum Ulm
  • Klinikum der Stadt Villingen-Schwenningen GmbH
  • Medizinische Universitätsklinik Würzburg
  • Semmelweis Medical University - Department of Cardiology
  • The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology
  • The University of Pecs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gold tip catheter

Platinum-iridium tip catheter

Arm Description

Gold tip catheter

Platinum-iridium tip catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ablation Success With the First Catheter
Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N). Positive final bidirectional cavotricuspid isthmus condution block test means "ablation successful". Negative final bidirectional cavotricuspid isthmus condution block test means "ablation unsuccessful"; ablation should be continued until success or terminated and classified as unsuccess.
Number of Patients With Long-term Treatment Success
No recurrence of atrial flutter after ablation
Number of Patients With Charred Catheter Tips
Char or coagulum formation on the catheter tip

Full Information

First Posted
May 12, 2006
Last Updated
February 3, 2010
Sponsor
Biotronik SE & Co. KG
search

1. Study Identification

Unique Protocol Identification Number
NCT00326001
Brief Title
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Official Title
AURUM 8 - Ablation of the Cavotricuspid Isthmus in Patients With Atrial Flutter Using an 8 mm Gold Alloy Tip Electrode
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biotronik SE & Co. KG

4. Oversight

5. Study Description

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.
Detailed Description
Transvenous catheter ablation has become the therapy of choice for patients with recurring, isthmus-dependent right atrial flutter. Achieving bidirectional conduction block in the cavotricuspid isthmus is decisive for both acute and long-term therapy success and essentially depends on the selected ablation method and the lesion size. By using an 8 mm tip electrode instead of a conventional 4 mm electrode, deeper lesions can be made, thus significantly reducing the required number of energy applications for achieving a bidirectional conduction block. Experimental studies have proven that using an ablation electrode made of gold alloy allows the creation of deeper lesions than with conventional platinum-iridium electrodes. Due to the greater heat conductivity of the gold alloy as opposed to platinum-iridium, the cooling of the ablation electrode is improved and more electric energy can be transmitted to the tissue at identical temperatures. The combination of both technologies in the form of an 8 mm-long gold electrode anticipates that the lesion depth required for an isthmus block can be achieved more quickly in comparison to the platinum-iridium electrode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Transvenous Catheter Ablation, Radiofrequency Catheter Ablation, Atrial flutter, Catheter Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gold tip catheter
Arm Type
Experimental
Arm Description
Gold tip catheter
Arm Title
Platinum-iridium tip catheter
Arm Type
Active Comparator
Arm Description
Platinum-iridium tip catheter
Intervention Type
Device
Intervention Name(s)
Gold tip catheter
Intervention Description
Radiofrquency ablation using gold tip catheter
Intervention Type
Device
Intervention Name(s)
Platinum-iridium tip catheter
Intervention Description
Radiofrequency ablation using platinum-iridium tip catheter
Primary Outcome Measure Information:
Title
Duration of Energy Application
Description
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.
Time Frame
ablation procedure
Secondary Outcome Measure Information:
Title
Ablation Success With the First Catheter
Description
Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N). Positive final bidirectional cavotricuspid isthmus condution block test means "ablation successful". Negative final bidirectional cavotricuspid isthmus condution block test means "ablation unsuccessful"; ablation should be continued until success or terminated and classified as unsuccess.
Time Frame
ablation procedure
Title
Number of Patients With Long-term Treatment Success
Description
No recurrence of atrial flutter after ablation
Time Frame
6 months after ablation
Title
Number of Patients With Charred Catheter Tips
Description
Char or coagulum formation on the catheter tip
Time Frame
ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Unstable medication in the last 7 days before study inclusion 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). Right atrial thrombus Late Exclusion Criteria: Patient included by accident Premature termination of the ablation procedure Atrial flutter not dependent on the posterior isthmus No conduction at the posterior isthmus before ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Lewalter, Assoc. Prof. Dr.
Organizational Affiliation
Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Clinical and Experimental Medicine
City
Praha
ZIP/Postal Code
14021
Country
Czech Republic
Facility Name
Universitätsklinik der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Kerckhoff Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Universitätsklinikum Charité, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitätsklinikum Charité, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Evangelisches Krankenhaus Düsseldorf
City
Duesseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Herzzentrum Duisburg
City
Duisburg
ZIP/Postal Code
47137
Country
Germany
Facility Name
Georg-August-Universität, Universitätsklinikum Göttingen
City
Goettingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Allgemeines Krankenhaus Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätskliniken des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Städtisches Krankenhaus München-Bogenhausen
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89070
Country
Germany
Facility Name
Klinikum der Stadt Villingen-Schwenningen GmbH
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
Medizinische Universitätsklinik Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Semmelweis Medical University - Department of Cardiology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
The University of Pecs
City
Pecs
ZIP/Postal Code
7624
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
16050836
Citation
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.
Results Reference
background
PubMed Identifier
16403084
Citation
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.
Results Reference
background
PubMed Identifier
23379836
Citation
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.
Results Reference
derived
PubMed Identifier
20876601
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs