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The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of the Solia CSP S pacing lead for LBBAP | Device | Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP) |
| Measure | Description | Time Frame |
|---|---|---|
| SADE-d free rate related to any investigatonal device | Rate of serious adverse device effects possible, probable or causal related to any investigational device. | throughout study duration, average of 4 years; annual evaluations |
| Rate of successful acute implantation in LBBAP using investigational devices in LBBAP | All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success. | Day 1 |
| Capture type at implantation | The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters. | Day 1 |
| Long-term maintenance of LBBAP | The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording. | throughout study duration, average of 4 years; annual evaluations |
| Electrical parameters - pacing threshold | The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms. | throughout study duration, average of 4 years; annual evaluations |
| Electrical parameters - sensing amplitude | The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads. | throughout study duration, average of 4 years; annual evaluations |
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Inclusion Criteria:
Exclusion Criteria:
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The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Pfaffenberger | Contact | +493068905 | 1318 | csp-stream@biotronik.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integral Healthcare | Not yet recruiting | Adelaide | Australia | |||
| Kepler Universitätsklinikum GmbH |
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| Electrical parameters - pacing impedance | The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads. | throughout study duration, average of 4 years; annual evaluations |
| Not yet recruiting |
| Linz |
| Austria |
| Fakultní nemocnice Olomouc | Not yet recruiting | Olomouc | Czechia |
| FN Kralovske Vinohrady | Not yet recruiting | Prague | Czechia |
| Hôpital Gabriel Montpied | Not yet recruiting | Clermont-Ferrand | France |
| Hôpital de la Timone | Not yet recruiting | Marseille | France |
| Centre Hospitalier Metz-Thionville | Not yet recruiting | Metz | France |
| Hôpital privé du Confluent | Not yet recruiting | Nantes | France |
| Hôpital Haut Lévêque | Not yet recruiting | Pessac | France |
| Universitäts-Herzzentrum Freiburg Bad Krozingen | Not yet recruiting | Bad Krozingen | Germany |
| Kerckhoff-Klinik GmbH | Not yet recruiting | Bad Nauheim | Germany |
| Herz- und Diabeteszentrum NRW | Not yet recruiting | Bad Oeynhausen | Germany |
| Krankenhaus Porz am Rhein gGmbH | Not yet recruiting | Cologne | Germany |
| Niels-Stensen-Kliniken, Marienhospital Osnabrück | Not yet recruiting | Osnabrück | Germany |
| Central Hospital of Northern Pest - Military Hospital | Recruiting | Budapest | Hungary |
| Semmelweis University | Not yet recruiting | Budapest | Hungary |
| University of Pécs | Recruiting | Pécs | Hungary |
| University of Szeged | Not yet recruiting | Szeged | Hungary |
| Assuta Medical Center | Not yet recruiting | Ashdod | Israel |
| Soroka Medical Center | Not yet recruiting | Beersheba | Israel |
| Hillel Yaffe Medical Center | Not yet recruiting | Hadera | Israel |
| Shaare Zedek MC | Not yet recruiting | Jerusalem | Israel |
| Tel Aviv Sourasky Medical Center | Not yet recruiting | Tel Aviv | Israel |
| Ospedale Di Summa - Perrino | Not yet recruiting | Brindisi | Italy |
| Niguarda Hospital | Not yet recruiting | Milan | Italy |
| A.O.U. Maggiore della Carita di Novara | Recruiting | Novara | Italy |
| Ospedale di Piove di Sacco | Not yet recruiting | Piove di Sacco | Italy |
| Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore | Not yet recruiting | Roma | Italy |
| SS Annunziata Taranto | Not yet recruiting | Taranto | Italy |
| Pauls Stradins Clinical University Hospital | Not yet recruiting | Riga | Latvia |
| Auckland City Hospital | Not yet recruiting | Grafton | New Zealand |
| Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra | Not yet recruiting | Coimbra | Portugal |
| Unidade Local de Saúde de Santa Maria, E. P. E. | Not yet recruiting | Lisbon | Portugal |
| Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta | Not yet recruiting | Lisbon | Portugal |
| Hospital Universitari Germans Trias i Pujol | Not yet recruiting | Barcelona | Spain |
| Hospital La Luz | Not yet recruiting | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Not yet recruiting | Valencia | Spain |
| Hospital Universitario La Fe | Not yet recruiting | Valencia | Spain |
| Inselspital, Universitätsspital Bern | Not yet recruiting | Bern | Switzerland |
| Universitätsspital Zürich (USZ) | Not yet recruiting | Zurich | Switzerland |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
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