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The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentus QP group | Patients with standard indication for CRT-D therapy who will be implanted with Sentus QP LV lead and the BIOTRONIK HF-T QP device. | ||
| VR-T/DR-T group | Patients with standard indication for ICD therapy who will be implanted with either single chamber ICD or dual chamber ICD of the Iperia ICD family |
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| Measure | Description | Time Frame |
|---|---|---|
| Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate | The safety of the LV lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the LV lead will be the basis for endpoint calculation of the SADE-free rate. | 3 months |
| Iperia ICD family: SADE free rate | The safety of the Iperia ICD family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| LV pacing threshold | Lv pacing threshold measured in the final programmed pacing vector | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of data of interest: Handling of LV lead during implantation | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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The patient collective consists mainly of heart failure patients with CRT-D indication according to current guidelines. In addition 50 patients with an indication for single or dual chamber ICD will be enrolled in the study. The investigator will select patients who are appropriate for particiation from his general patient population.
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| Name | Affiliation | Role |
|---|---|---|
| Werner Jung, Prof. Dr. | Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum | Sankt Pölten | Austria | ||||
| Aalborg University Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
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| Aalborg |
| Denmark |
| Odense University Hospital | Odense | Denmark |
| Aarhus University Hospital | Skejby | Denmark |
| Jyväskylä Central Hospital | Jyväskylä | Finland |
| Herz- und Diabetes Zentrum | Bad Oeynhausen | Germany |
| SRH Wald-Klinikum | Gera | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| UKSH Campus Lübeck | Lübeck | Germany |
| Märkische Kliniken Lüdenscheid | Lüdenscheid | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | Germany |
| Klinikum München-Bogenhausen | Munich | Germany |
| Johanniter Krankenhaus | Stendal | Germany |
| Schwarzwald-Baar Klinikum | Villingen-Schwenningen | 78048 | Germany |
| Ospedale Pugliese Ciaccio | Catanzaro | Italy |
| Paul Stradins Clinical University Hospital | Riga | Latvia |
| University Medical Center Groningen | Groningen | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| National Heart Centre | Singapore | Singapore |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Kantonsspital Lucerne | Lucerne | Switzerland |
| Cardiocentro Ticino | Lugano | Switzerland |
| Triemlispital Zurich | Zurich | Switzerland |
| Russels Hall Hospital | Brighton | United Kingdom |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |