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

Primary Purpose

Atrial Flutter

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
RF ablation of the cavo-tricuspid isthmus
cryo ablation of the cavo-tricuspid isthmus
irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
cryo 6.5mm tip ablation of the cavotricuspid isthmus
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herz-Zentrum Bad Krozingen
  • Westfälische Wilhelms-Universitaet Muenster
  • Deutsches Herzzentrum Muenchen
  • Klinikum Nuernberg Sued

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

8mm tip ablation catheter for ablation of cavotricuspid isthmus

irrigated tip ablation catheter for ablation of cavotricuspid isthmus

cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus

Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus

Outcomes

Primary Outcome Measures

Acute Efficacy (bidirectional cavotricuspid isthmus block)
Long-term efficacy (6 months FU freedom of typical atrial flutter)
Mortality

Secondary Outcome Measures

Patients' pain scores during ablation
Safety of ablational devices

Full Information

First Posted
September 12, 2005
Last Updated
March 18, 2008
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00196170
Brief Title
Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter
Official Title
Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2003 (undefined)
Primary Completion Date
April 2008 (Anticipated)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
8mm tip ablation catheter for ablation of cavotricuspid isthmus
Arm Title
2
Arm Type
Experimental
Arm Description
irrigated tip ablation catheter for ablation of cavotricuspid isthmus
Arm Title
3
Arm Type
Experimental
Arm Description
cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus
Arm Title
4
Arm Type
Experimental
Arm Description
Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus
Intervention Type
Procedure
Intervention Name(s)
RF ablation of the cavo-tricuspid isthmus
Intervention Description
8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
Intervention Type
Procedure
Intervention Name(s)
cryo ablation of the cavo-tricuspid isthmus
Intervention Description
Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
Intervention Type
Procedure
Intervention Name(s)
irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
Intervention Description
irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
Intervention Type
Procedure
Intervention Name(s)
cryo 6.5mm tip ablation of the cavotricuspid isthmus
Intervention Description
cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
Primary Outcome Measure Information:
Title
Acute Efficacy (bidirectional cavotricuspid isthmus block)
Time Frame
bidirectional cavotricuspid isthmus block
Title
Long-term efficacy (6 months FU freedom of typical atrial flutter)
Time Frame
6 months
Title
Mortality
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patients' pain scores during ablation
Time Frame
while hospitalisation
Title
Safety of ablational devices
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Schmitt, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernhard Zrenner, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz-Zentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Westfälische Wilhelms-Universitaet Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Klinikum Nuernberg Sued
City
Nuernberg
ZIP/Postal Code
90471
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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