NCT00196170

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

Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Flutter

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-05-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2005-09-20
• Last updated: 2008-03-19

Locations

4 sites across 1 country: Germany