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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 8mm tip ablation catheter for ablation of cavotricuspid isthmus |
|
| 2 | Experimental | irrigated tip ablation catheter for ablation of cavotricuspid isthmus |
|
| 3 | Experimental | cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus |
|
| 4 | Experimental | Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF ablation of the cavo-tricuspid isthmus | Procedure | 8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' pain scores during ablation | while hospitalisation | |
| Safety of ablational devices | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Schmitt, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Bernhard Zrenner, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz-Zentrum Bad Krozingen | Bad Krozingen | 79189 | Germany | |||
| Deutsches Herzzentrum Muenchen |
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| cryo ablation of the cavo-tricuspid isthmus | Procedure | Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter |
|
| irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus | Procedure | irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter |
|
| cryo 6.5mm tip ablation of the cavotricuspid isthmus | Procedure | cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter |
|
| Munich |
| 80636 |
| Germany |
| Westfälische Wilhelms-Universitaet Muenster | Münster | 48149 | Germany |
| Klinikum Nuernberg Sued | Nuremberg | 90471 | Germany |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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