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| ID | Type | Description | Link |
|---|---|---|---|
| 533/2025/Sper/AOUBo | Other Identifier | Comitato Etico AVEC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction System Pacing (CSP) | Experimental | 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. |
|
| Conventional System Pacing/Right Ventricular (RV) Pacing | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction System Pacing (CSP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure | composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions | 36 months after the PM implant |
| Measure | Description | Time Frame |
|---|---|---|
| number of HF events | number of HF events | 36 months after the PM implant |
| HF hospitalizations | HF hospitalizations | 36 months after the PM implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauro Biffi, MD | Contact | +390512149034 | mauro.biffi@aosp.bo.it | |
| Susanna Maltoni, PharmD | Contact | +390512141326 | susanna.maltoni@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Mauro Biffi, MD | IRCCS AOUBO Policlinico di Sant'Orsola | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedal iera "Card. G. Panico" | Not yet recruiting | Bari | Italy |
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|
| Right Ventricular (RV) Pacing | Procedure | 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 |
|
| HF non-pharmacological interventions | HF non-pharmacological interventions | 36 months after the PM implant |
| IRCCS AOUBO Policlinico di Sant'orsola | Recruiting | Bologna | 40138 | Italy |
|
| Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco" | Not yet recruiting | Catania | Italy |
|
| Azienda Ospedaliero-Universitaria di Ferrara | Recruiting | Ferrara | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Not yet recruiting | Milan | Italy |
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| Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara | Not yet recruiting | Novara | Italy |
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| Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia | Not yet recruiting | Novara | Italy |
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| Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone | Not yet recruiting | Palermo | Italy |
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| Azienda Ospedaliero-Universitaria di Parma | Not yet recruiting | Parma | Italy |
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| Azienda Ospedaliera Santa Maria della Misericordia | Not yet recruiting | Perugia | Italy |
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| Policlinico Casilino | Not yet recruiting | Roma | Italy |
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| Ospedale di Rovigo Aulss 5 Polesana | Not yet recruiting | Rovigo | Italy |
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| Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico | Not yet recruiting | Torino | Italy |
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| APSS Trento - Ospedale S. Maria del Carmine di Rovereto | Not yet recruiting | Trento | Italy |
|
| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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