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The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SD01 ICD lead | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of appropriate sensing and pacing | The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up. | at the 3-month follow-up |
| Serious adverse device effects (SADEs) related to the SD01 lead | until the 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pacing threshold between Linoxsmart and SD01 | Comparison of the manually measured pacing threshold of the SD01 lead system to the Linox SD lead at 3-month follow-up. The idea is that the pacing threshold will be similar within a suitable range. | at the 3-month follow-up |
| Shift rate of the painless shock impedance measurement |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication
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| Name | Affiliation | Role |
|---|---|---|
| Roland Richard Tilz, Prof. Dr. med. | University Clinic of Schleswig-Holstein, Lübeck, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Ann University Hospital | Brno | Czechia | ||||
| CHU de Saint-Etienne |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| between 3- and 6-month follow-up |
| Saint-Etienne |
| France |
| Hopital Civil Strasbourg | Strasbourg | France |
| Helios Klinik Aue | Aue | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany |
| Universitätsklinik Jena | Jena | Germany |
| University Clinic of Schleswig-Holstein | Lübeck | Germany |
| Carl-von-Basedow Clinic | Merseburg | Germany |
| Städtisches Klinikum München Bogenhausen | München | Germany |
| Klinik Rothenburg | Rothenburg upon Tauber | Germany |
| Universitätsklinik Würzburg | Würzburg | Germany |
| Semmelweiss University Hospital | Budapest | Hungary |
| University of Debrecen | Debrecen | Hungary |
| Bovas P. Stradina KUS Latvian Center of Cardiology | Riga | Latvia |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |