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Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196170
First received: September 12, 2005
Last updated: March 18, 2008
Last verified: March 2008

September 12, 2005
March 18, 2008
May 2003
April 2008   (final data collection date for primary outcome measure)
  • Acute Efficacy (bidirectional cavotricuspid isthmus block) [ Time Frame: bidirectional cavotricuspid isthmus block ] [ Designated as safety issue: No ]
  • Long-term efficacy (6 months FU freedom of typical atrial flutter) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Acute Efficacy (bidirectional cavotricuspid isthmus block)
  • Long-term efficacy (6 months FU freedom of typical atrial flutter)
  • Mortality
Complete list of historical versions of study NCT00196170 on ClinicalTrials.gov Archive Site
  • Patients' pain scores during ablation [ Time Frame: while hospitalisation ] [ Designated as safety issue: No ]
  • Safety of ablational devices [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patients' pain scores during ablation
  • Safety of ablational devices
Not Provided
Not Provided
 
Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter
Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter

This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique regarding the acute and long term efficacy and safety.

This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique. The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. However, ablation with RF is painful since the underlying cardiac tissue heats up (up to 70-80°C inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. Cryo-ablation, which destroys tissue by freezing it down to -80 to -90°C, is thought to be less painful or even painless with the same efficacy than RF ablation.

The acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Flutter
  • Procedure: RF ablation of the cavo-tricuspid isthmus
    8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
  • Procedure: cryo ablation of the cavo-tricuspid isthmus
    Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
  • Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
    irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
  • Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus
    cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
  • Experimental: 1
    8mm tip ablation catheter for ablation of cavotricuspid isthmus
    Intervention: Procedure: RF ablation of the cavo-tricuspid isthmus
  • Experimental: 2
    irrigated tip ablation catheter for ablation of cavotricuspid isthmus
    Intervention: Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
  • Experimental: 3
    cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus
    Intervention: Procedure: cryo ablation of the cavo-tricuspid isthmus
  • Experimental: 4
    Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus
    Intervention: Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
July 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age between 18 and 80 years
  • documented atrial flutter which is most probably typical isthmus dependent atrial flutter
  • informed written consent

Exclusion Criteria:

  • prior ablation for atrial flutter
  • concomitant arrhythmia which is treated during the same ablation procedure
  • prior MAZE operation
  • contra indication for catheterization
  • physical or psychiatric disorder making participation in the study impossible
  • pregnancy
  • prior participation in the study
  • participation in another study
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00196170
GE IDE No. C00303
Yes
Prof. A. Schömig, Deutsches Herzzentrum Munich
Deutsches Herzzentrum Muenchen
Boston Scientific Corporation
Study Chair: Claus Schmitt, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Bernhard Zrenner, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP