Atrioventricular Block
Conditions
Brief summary
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.
Interventions
PROCEDUREConduction System Pacing (CSP)
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.
PROCEDURERight Ventricular (RV) Pacing
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
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia/atrial fibrillation (AT/AF), or with slow AV conduction during AT/AF, or undergoing AV node ablation + ventricular stimulation * male and female * acquired informed consent
Exclusion criteria
* Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT) * Ejection Fraction \< 35% * Life expectancy \< 2 years * Participation in another clinical trial which might impact on the study outcome * Pregnancy, except as "In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason/s for non-randomization."
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure | 36 months after the PM implant | composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of HF events | 36 months after the PM implant | number of HF events |
| HF hospitalizations | 36 months after the PM implant | HF hospitalizations |
| HF non-pharmacological interventions | 36 months after the PM implant | HF non-pharmacological interventions |
Countries
Italy
Contacts
CONTACTMauro Biffi, MD
CONTACTSusanna Maltoni, PharmD
PRINCIPAL_INVESTIGATORMauro Biffi, MD
IRCCS AOUBO Policlinico di Sant'Orsola
Outcome results
None listed