Overview

This trial is active, not recruiting.

Condition atrial flutter
Treatments 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
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Collaborator Boston Scientific Corporation
Start date May 2003
End date April 2008
Trial size 500 participants
Trial identifier NCT00196170, GE IDE No. C00303

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
8mm tip ablation catheter for ablation of cavotricuspid isthmus
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)
irrigated tip ablation catheter for ablation of cavotricuspid isthmus
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)
cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus
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)
Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus
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

Primary Outcomes

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

Secondary Outcomes

Measure
Patients' pain scores during ablation
time frame: while hospitalisation
Safety of ablational devices
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
Principal investigator Bernhard Zrenner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.