Two-year outcomes of left bundle branch area pacing versus traditional right ventricular pacing in middle-aged adults: a registry-based trial.
Matteo Bertini, Luca Canovi, Francesco Vitali...
https://pubmed.ncbi.nlm.nih.gov/40880214Actively Recruiting
Led by University Hospital of Ferrara · Updated on 2024-03-22
8400
Participants Needed
31
Research Sites
52 weeks
Total Duration
Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches: conventional right ventricular pacing, conduction system pacing (such as His bundle or left bundle branch area pacing), cardiac resynchronization therapy (CRT) with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.
CONDITIONS
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Implantation procedure day
Participants undergo implantation of a cardiac pacing device using one of several approaches, including conventional right ventricular pacing, conduction system pacing, cardiac resynchronization therapy, epicardial pacing, or leadless pacing.
1 visit (in-person) for device implantation
Duration - 30 days
Participants are monitored for device efficacy and safety, including stable electrical parameters, absence of cardiovascular hospitalizations and death, and procedural complications within 30 days post-implantation.
1 to 2 visits within 30 days
Duration - Up to 120 months
Participants are followed for up to 120 months to assess long-term efficacy and safety of the cardiac pacing device, including heart failure onset or worsening, arrhythmias, device function, infections, and need for re-intervention.
Periodic visits as per clinical practice over 10 years
Total: 31 locations
1
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, FE, Italy, 44124
Actively Recruiting
2
Ospedale San Donato
Arezzo, Italy
Actively Recruiting
3
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna
Bologna, Italy, 40138
Actively Recruiting
4
spedale Maggiore di Bologna
Bologna, Italy
Actively Recruiting
5
Ospedale Bernardino Ramazzini
Carpi, Italy
Actively Recruiting
6
Ospedale SS Annunziata
Cento, Italy
Actively Recruiting
7
Ospedale Bufalini
Cesena, Italy
Actively Recruiting
8
Ospedale San Giuseppe
Empoli, Italy
Actively Recruiting
9
Ospedale di Vaio
Fidenza, Italy
Actively Recruiting
10
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Actively Recruiting
11
Ospedale San Giovanni di Dio
Florence, Italy
Actively Recruiting
12
Ospedale Santa Maria Annunziata Bagno a Ripoli
Florence, Italy
Actively Recruiting
13
Azienda Ospedaliero-Universitaria "Ospedali Riuniti"
Foggia, Italy
Actively Recruiting
14
Ospedale Morgagni-Pierantoni
Forlì, Italy
Actively Recruiting
15
Ospedale Santa Maria della Misericordia Grosseto
Grosseto, Italy
Actively Recruiting
16
Ospedale della Versilia
Lido di Camaiore, Italy
Actively Recruiting
17
Ospedali Riuniti di Livorno
Livorno, Italy
Actively Recruiting
18
Ospedale San Luca
Lucca, Italy
Actively Recruiting
19
Nuovo ospedale Apuano Massa
Massa, Italy
Actively Recruiting
20
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy
Actively Recruiting
21
Ospedale Sant'Agostino Estense Modena Baggiovara
Modena, Italy
Actively Recruiting
22
Ospedale Civico, azienda Ospedaliera di Palermo
Palermo, Italy
Actively Recruiting
23
Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
24
Azienda Ospedaliero-Universitaria Maggiore
Parma, Italy
Actively Recruiting
25
Ospedale Guglielmo da Saliceto Piacenza
Piacenza, Italy, 29100
Actively Recruiting
26
Azienda Ospedaliero-Universitaria pisana Cisanello
Pisa, Italy
Actively Recruiting
27
Fondazione Toscana Gabriele Monasterio
Pisa, Italy
Actively Recruiting
28
Ospedale Santa Maria delle Croci
Ravenna, Italy
Actively Recruiting
29
ASMN Reggio Emilia
Reggio Emilia, Italy
Actively Recruiting
30
Ospedale degli Infermi Rimini
Rimini, Italy
Actively Recruiting
31
Azienda Ospedaliero-Universitaria Senese
Siena, Italy
Actively Recruiting
M
Matteo Bertini, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Matteo Bertini, Luca Canovi, Francesco Vitali...
https://pubmed.ncbi.nlm.nih.gov/40880214Matteo Bertini, Francesco Vitali, Michele Malagù...
https://pubmed.ncbi.nlm.nih.gov/40439650