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The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock_BC (Ilivia Neo, Intica Neo) implant and programmer software features.
The new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky).
The goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorSky ICD or CRT-D | Device | Subjects with an indication for an ICD or CRT-D device will be implanted with a CorSky device of the CorSky ICD family according to standard implantation procedures. Device programming will be done according to the medical needs of the subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| CorSky-related SADE-d free rate at 6 months | CorSky-related SADE-d free rate at 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Standard indication for ICD or CRT-D
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anja Viehrig, Dr. rer. nat. | Contact | +49(0)1516890-1304 | anja.viehrig@biotronik.com | |
| Konstantinia Skreka, Dr. rer. nat. | Contact | 030-68905 2949 | konstantinia.skreka@biotronik.com |
| Name | Affiliation | Role |
|---|---|---|
| Alan Bulava, MD, PhD, Prof. Dr. | Fakultní nemocnice Olomouc, CZE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Recruiting | Graz | Styria | 8010 | Austria |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| Fakultní nemocnice u sv. Anny v Brně | Recruiting | Brno | CZ-65691 | Czechia |
|
| Nemocnice Ceske Budejovice, a.s. | Recruiting | České Budějovice | 37001 | Czechia |
|
| Universitätsklinikum Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
|
| SRH Wald-Klinikum Gera GmbH | Recruiting | Gera | Thuringia | 07548 | Germany |
|
| Semmelweis University | Recruiting | Budapest | 1122 | Hungary |
|
| University of Pécs | Recruiting | Pécs | H-7624 | Hungary |
|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |