Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied interventions in terms of quality of life and cost-effectiveness for the treatment of patients with atrioventricular block. 1260 adult patients who are candidates for pacemaker implantation for the treatment of atrioventricular conduction disease will be randomised to stimulation of the conduction system or to the conventional stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,260
CSP occurs at the left endocardic surface of the interventricular septum hence specifically designed delivery catheters are used to advance the ventricular lead across the septum until its left-sided edge, where the Left Bundle is located. To determine whether CSP has been achieved, a standard 12-lead electrocardiogram (ECG) is continuously recorded.
RV pacing delivered either at the RV apex or RV septum. RV pacing is delivered by single chamber or dual chamber pacemakers depending on patients' rhythm (sinus or AT/AF) according to well-established clinical practice as described in the EHRA recommendtions
Azienda Ospedal iera "Card. G. Panico"
Bari, Italy
Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
Catania, Italy
Azienda Ospedalie ro-Universitaria di Ferrara
Ferrara, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
Novara, Italy
Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
Palermo, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Azienda Ospedaliera Santa Maria della Misericordia
Perugia, Italy
Policlinico Casilino
Roma, Italy
...and 3 more locations
Heart failure
composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions
Time frame: 36 months after the PM implant
number of HF events
number of HF events
Time frame: 36 months after the PM implant
HF hospitalizations
HF hospitalizations
Time frame: 36 months after the PM implant
HF non-pharmacological interventions
HF non-pharmacological interventions
Time frame: 36 months after the PM implant
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