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

NCT ID: NCT00196170

Last Updated: 2008-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

8mm tip ablation catheter for ablation of cavotricuspid isthmus

Group Type EXPERIMENTAL

RF ablation of the cavo-tricuspid isthmus

Intervention Type PROCEDURE

8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter

2

irrigated tip ablation catheter for ablation of cavotricuspid isthmus

Group Type EXPERIMENTAL

irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus

Intervention Type PROCEDURE

irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter

3

cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus

Group Type EXPERIMENTAL

cryo ablation of the cavo-tricuspid isthmus

Intervention Type PROCEDURE

Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter

4

Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus

Group Type EXPERIMENTAL

cryo 6.5mm tip ablation of the cavotricuspid isthmus

Intervention Type PROCEDURE

cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Deutsches Herzzentrum Munich

Principal Investigators

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Claus Schmitt, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Bernhard Zrenner, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Herz-Zentrum Bad Krozingen

Bad Krozingen, , Germany

Site Status

Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status

Westfälische Wilhelms-Universitaet Muenster

Münster, , Germany

Site Status

Klinikum Nuernberg Sued

Nuremberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GE IDE No. C00303

Identifier Type: -

Identifier Source: org_study_id