Atrial Flutter
Conditions
Brief 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.
Interventions
PROCEDURERF 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
PROCEDUREcryo 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
PROCEDUREirrigated 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
PROCEDUREcryo 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
Boston Scientific Corporation
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Efficacy (bidirectional cavotricuspid isthmus block) | bidirectional cavotricuspid isthmus block |
| Long-term efficacy (6 months FU freedom of typical atrial flutter) | 6 months |
| Mortality | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Patients' pain scores during ablation | while hospitalisation |
| Safety of ablational devices | 6 months |
Countries
Germany
Outcome results
None listed