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Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamira ICD lead family | Device | Implantation, measurements and follow-up schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pamira lead related SADE-d free rate at 6 months after implantation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation | 3 months, 12 months | |
| 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up | 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Deneke, Prof. | RHÖN-KLINIKUM Campus Bad Neustadt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hunter Hospital | New Lambton Heights | New South Wales | NSW 2305 | Australia | ||
| Medizinische Universität Graz |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2026 | |
| Reset | Feb 17, 2026 | |
| Release | Mar 18, 2026 |
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| 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up | 6 months, 12 months |
| Graz |
| Styria |
| Austria |
| UZ Brussels | Jette | Belgium |
| UZ Leuven Gasthuisberg | Leuven | Belgium |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | Germany |
| Klinikum der Universität München | München | Bavaria | Germany |
| Universitätsklinikum Würzburg | Würzburg | Bavaria | Germany |
| Immanuel Klinikum Bernau Herzzentrum Brandenburg | Bernau bei Berlin | Brandenburg | Germany |
| St. Marienkrankhaus Klinikum Westmünsterland GmbH | Ahaus | North Rhine-Westphalia | Germany |
| Städtisches Klinikum Dresden-Friedrichstadt | Dresden | Saxony | Germany |
| Otto-von-Guericke-Universität Magdeburg | Magdeburg | Saxony-Anhalt | Germany |
| Klinikum Dorothea Christiane Erxleben Quedlinburg | Quedlinburg | Saxony-Anhalt | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | Thuringia | Germany |
| SRH Zentralklinikum Suhl GmbH | Suhl | Thuringia | Germany |
| Städtisches Klinikum Brandenburg GmbH | Brandenburg | Germany |
| State Hospital of Cardiology | Balatonfüred | Hungary |
| Semmelweis University | Budapest | Hungary |
| The University of Pécs | Pécs | Hungary |
| Assuta Medical Center | Ashdod | Israel |
| Soroka Medical Center | Beersheba | Israel |
| Shaare Zedek MC | Jerusalem | Israel |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.) | Banská Bystrica | Slovakia |
| Reset | Apr 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2026 | Feb 17, 2026 | |||
| Mar 18, 2026 | Apr 6, 2026 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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