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

NCT00196170 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2008-03-19

No results posted yet for this study

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.

Conditions

  • Atrial Flutter

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Claus Schmitt, MD · Deutsches Herzzentrum Muenchen

  • Bernhard Zrenner, MD · Deutsches Herzzentrum Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2008-04-30
Completion
2008-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196170 on ClinicalTrials.gov