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
  Purpose

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.


Condition Intervention Phase
Atrial Flutter
Procedure: RF ablation of the cavo-tricuspid isthmus
Procedure: cryo ablation of the cavo-tricuspid isthmus
Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: May 2003
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
8mm tip ablation catheter for ablation of cavotricuspid isthmus
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
Experimental: 2
irrigated tip ablation catheter for ablation of cavotricuspid isthmus
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
Experimental: 3
cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus
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
Experimental: 4
Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196170

Locations
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Westfälische Wilhelms-Universitaet Muenster
Muenster, Germany, 48149
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Klinikum Nuernberg Sued
Nuernberg, Germany, 90471
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Boston Scientific Corporation
Investigators
Study Chair: Claus Schmitt, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Bernhard Zrenner, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00196170     History of Changes
Other Study ID Numbers: GE IDE No. C00303
Study First Received: September 12, 2005
Last Updated: March 18, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014