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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)
SADE-d free rate related to any investigatonal device
Rate of serious adverse device effects possible, probable or causal related to any investigational device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: throughout study duration, average of 4 years; annual evaluations
Electrical parameters - pacing impedance
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Integral Healthcare
Adelaide, Australia
NOT_YET_RECRUITINGKepler Universitätsklinikum GmbH
Linz, Austria
NOT_YET_RECRUITINGFakultní nemocnice Olomouc
Olomouc, Czechia
NOT_YET_RECRUITINGFN Kralovske Vinohrady
Prague, Czechia
NOT_YET_RECRUITINGHôpital Gabriel Montpied
Clermont-Ferrand, France
NOT_YET_RECRUITINGHôpital de la Timone
Marseille, France
NOT_YET_RECRUITINGCentre Hospitalier Metz-Thionville
Metz, France
NOT_YET_RECRUITINGHôpital privé du Confluent
Nantes, France
NOT_YET_RECRUITINGHôpital Haut Lévêque
Pessac, France
NOT_YET_RECRUITINGUniversitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
NOT_YET_RECRUITING...and 30 more locations
The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.
Time frame: throughout study duration, average of 4 years; annual evaluations