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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany
Deutsches Herzzentrum Muenchen
Munich, Germany
Westfälische Wilhelms-Universitaet Muenster
Münster, Germany
Klinikum Nuernberg Sued
Nuremberg, Germany
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
Patients' pain scores during ablation
Time frame: while hospitalisation
Safety of ablational devices
Time frame: 6 months
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cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter