Left Ventricular Mechanical Insights Into Left Bundle Branch Pacing and Left Ventricular Septal Pacing.
Matteo Bertini, Francesco Vitali, Michele Malagù...
https://pubmed.ncbi.nlm.nih.gov/40439650/Actively 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
M
Matteo Bertini, MD, PhD
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University Hospital of Ferrara
Lead Sponsor
You may qualify if you...
You will not qualify if you...
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
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, Francesco Vitali, Michele Malagù...
https://pubmed.ncbi.nlm.nih.gov/40439650/Matteo Bertini, Luca Canovi, Francesco Vitali...
https://pubmed.ncbi.nlm.nih.gov/40880214/University Hospital of Ferrara
Lead Sponsor