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| Name | Class |
|---|---|
| CryoCath Technologies Inc. | INDUSTRY |
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In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application.
The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy of this approach is very high.
However, the potential complication of higher degree AV conduction block, requiring in some instances implantation of a pacemaker, is a major drawback of this approach.
We want to compare in this randomized study the safety and efficacy of standard RF ablation with the cryo-ablation technique. This relatively new technique is thought to offer more safety concerning higher degree AV conduction block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
|
| 2 | Experimental | cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF-ablation | Procedure | RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data. | 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 |
|---|---|---|---|---|---|---|
| Kerckhoffklinik GmbH EPU | Bad Nauheim | 61231 | Germany | |||
| Charite Berlin Virchow - Klinikum Med. Klinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21098435 | Result | Deisenhofer I, Zrenner B, Yin YH, Pitschner HF, Kuniss M, Grossmann G, Stiller S, Luik A, Veltmann C, Frank J, Linner J, Estner HL, Pflaumer A, Wu J, von Bary C, Ucer E, Reents T, Tzeis S, Fichtner S, Kathan S, Karch MR, Jilek C, Ammar S, Kolb C, Liu ZC, Haller B, Schmitt C, Hessling G. Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial. Circulation. 2010 Nov 30;122(22):2239-45. doi: 10.1161/CIRCULATIONAHA.110.970350. Epub 2010 Nov 15. |
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| cryo ablation |
| Procedure |
Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
|
| Berlin |
| 13353 |
| Germany |
| Universitaetsklinikum Bonn Med. Klinik II | Bonn | 53105 | Germany |
| Evangelisches Krankenhaus Duesseldorf Kardiologie | Düsseldorf | 40217 | Germany |
| Universitaetsklinikum Giessen EPU | Giessen | 35392 | Germany |
| Klinikum Luedenscheid Kardiologie | Lüdenscheid | 58515 | Germany |
| Klinikum der Stadt Mannheim Med. Klinik I | Mannheim | 68167 | Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| Universitaetsklinikum Tuebingen Med. Klinik/Abt.III | Tübingen | 72076 | Germany |
| Universitaetsklinikum Ulm Innere Med. II | Ulm | 89075 | Germany |
| ID | Term |
|---|---|
| D013611 | Tachycardia, Atrioventricular Nodal Reentry |
| ID | Term |
|---|---|
| D054139 | Tachycardia, Reciprocating |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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