An observational study in Arrhythmias, Cardiac, Atrioventricular Block and Reduced Systolic Function, sponsored by University Hospital of Ferrara. Recruiting at 31 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by University Hospital of Ferrara · Observational
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.
Participants [patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.
Cardiac pacing with implantable electronic cardiac devices and transvenous leads has been introduced since 1960 and is considered a safe, effective and low-risk therapy. The most common indications for permanent cardiac pacing are sinus node dysfunction and atrioventricular blocks. In Europe, pacemaker implants exceed 1000 per million inhabitants. The aim of this therapy is not only to improve patients survival but also their quality of life, which is an essential aspect in assessing patients clinical status and prognosis.
Nowadays, five types of cardiac pacing are recognised in clinical practice:
These pacing modalities have different possibilities to restore a normal cardiac electromechanical activation, resulting in different degrees of mechanical efficiency in terms of systolic output and diastolic pressures, with consequent effects on improvement/onset of heart failure and cardiopulmonary performance of our patients.
Right ventricular pacing induces a dyssynchronous cardiac activation pattern that can lead to left systolic dysfunction and a consequent increased risk of death related to the development of heart failure.
These observations led to the study of alternative cardiac pacing modalities since the 1990s, in order to improve the clinical outcome of patients with symptomatic bradyarrhythmias. The study of pathological ventricular activation due to left bundle-branch block represents the pathophysiological premise of cardiac resynchronisation in patients with systolic dysfunctional heart failure, and constitutes the developmental model for physiological pacing.
CRT improves mortality and quality of life in patients with heart failure and reduced left ventricular ejection fraction. Typically left ventricular pacing is achieved by placing a catheter in the posterolateral area through a venous branch of the coronary sinus. Unfortunately, despite several years of experience in this field, clinical non-response to this therapy is observed in between 20% and 40% of patients, mostly due to the inability to reach the appropriate pacing site because of anatomical difficulties/absence of veins in the target area.
Recently, conduction system pacing (CSP) has rapidly emerged as an alternative pacing modality to both right ventricular pacing (RVP) and CRT, in order to achieve a more physiological pacing. His bundle pacing (HBP) is considered the physiological pacing "par excellence", but the results in literature show rather frequent technical difficulties due to high pacing thresholds, inadequate ventricular signal amplitude for the detection of intrinsic cardiac activity, low success rate and risk of progression of conduction system pathology in patients with infranodal conduction defects.
Left bundle area pacing has more recently emerged as a viable alternative to achieve physiological pacing with haemodynamic parameters similar to those of HBP, but with lower and stable pacing thresholds, ventricular signal amplitude adequate for the detection of intrinsic cardiac activity and high success rate.
Several experiences with different pacing systems have been published, mainly single-centre studies with small sample sizes and different definitions of conduction system pacing success.
In non-randomised comparative studies, and thus with methodological limitations, clinical superiority over conventional right ventricular pacing, and a substantial efficacy equivalent to CRT in patients with left bundle-branch block, has been shown, creating the preconditions for widespread use of the CSP.
Considering, therefore, the widespread use of the latter technique and the high rate of implants that can potentially benefit from physiological pacing, evaluating safety, feasibility, timing and benefits becomes more crucial than ever.
Therefore, the goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres.
The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.
The investigators will collect clinical and procedural data from patients with an indication for permanent cardiac pacing who have consecutively undergone an implantable electronic device implant procedure at the Electrophysiology Laboratories of the participating centres over a period of 120 months from the time of approval with a follow-up of an equal 120 months.
Patients will be classified according to the type of stimulation:
Conduction system pacing:
The investigators defined efficacy at 30 days the presence of stable electrical parameters - or, if unstable, not requiring early re-intervention, the absence of cardiovascular hospitalizations and the absence of cardiovascular death.
The investigators defined safety at 30 days the absence of procedural complications, such as haematoma requiring re-intervention or with haemoglobin loss >2gr/dl, pneumothorax, pericardial effusion requiring drainage, lead dislocation, cardiac implantable electronic device (CIED) infection or a re-intervention for any cause.
Equally, the investigators defined efficacy at 6-12 months the presence of stable electrical parameters - or, if unstable, not requiring re-intervention, the absence of cardiovascular hospitalizations, the absence of cardiovascular death, the occurrence of heart failure, the occurrence or worsening of atrial or ventricular tachyarrhythmias.
Therefore, the investigators defined safety at 6-12 months the proper functioning of the device, the absence of infection and the absence of re-intervention for any cause.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 8,400 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 28 are open to participants now.
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Patients with an indication for permanent cardiac stimulation who have subsequently undergone an implantation procedure for an implantable electronic device at the Electrophysiology Laboratories of participating centers within a period of 120 months from the time of approval, with a corresponding follow-up period of another 120 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The device (pace maker or implantable cardiac defibrillator) is implanted in the subcutaneous subclavian area (right or left) and it is connected to transvenous lead/leads (active or passive) implanted in the right cardiac chambers (atrium and ventricle or ventricle only), which detect intrinsic electrical activity and stimulate when needed. The ventricle pacing might be obtained with an apical or septal stimulation. Vascular access might be from the cephalic, axillary or subclavian veins. Once positioned, lead's pacing threshold, sensing and impedance are measured. If the investigators find good and stable electrical parameters, the catheter(s) is(are) fixed and left in place.
Device: Cardiac pacing - Conventional RV pacing
The approach for the insertion of the device and of the transvenous leads is similar to the previous ones. The ventricle activation might be obtained with the his bundle stimulation or with the left bundle branch area pacing downstream of the conduction block. Vascular access might be from the cephalic, axillary or subclavian veins. Both selective and non-selective stimulation of the His bundle and the stimulation of the left bundle branch and left septum are considered successful. In both cases, attempts are made to locate the atrio-ventricular junction by fluoroscopic methods or with three-dimensional electroanatomical mapping system. The Hisian potential is sought and the catheter is positioned. In the LBBAP the investigators place the lead 1.5 cm below the His region and, with the pacemaking method, the investigators identify an area that electrocardiographically shows a W signal in V1 lead with D2 more positive than D3 - after checking the electrical parameters.
Device: Cardiac pacing - Conduction System Pacing
The approach for the insertion of the device and of the transvenous leads is similar to the previous ones. The right ventricle pacing (with a pacing lead or a defibrillation coil) might be obtained with an apical or septal stimulation, while the left ventricular pacing is achieved by placing a catheter (active or passive) in the posterolateral area through a venous branch of the coronary sinus. Cardiac resynchronisation therapy (CRT) delivers biventricular or left ventricular only pacing. Vascular access might be from the cephalic, axillary or subclavian veins. Once positioned, lead's pacing threshold, sensing and impedance are measured. If the investigators find good and stable electrical parameters, the catheter(s) is(are) fixed and left in place - paying attention to the phrenic nerve capture threshold.
Device: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
The device is usually placed in the subcutaneous abdominal area and the lead(s) is(are) secured in the epicardial surface. It is often used in congenital heart defects or post-cardiac surgery scenarios. Surgeons may access the epicardium during open-heart surgery or with minimally invasive techniques.
Device: Cardiac pacing - Epicardial pacing
The leadless device is placed via a percutaneous approach through a large-calibre (femoral) vein inside the right ventricle. It is suitable for patients needing a single chamber pacing such as patients with permanent atrial fibrillation with slow ventricular response, in some cases of paroxysmal atrioventricular block, or patients with a history of CIED infections. The only one currently available has a cardiac muscle fixation system consisting of 4 self-expanding barbs. Once positioned, pacing threshold, sensing and impedance are measured. If the investigators find good and stable electrical parameters, the catheter is left in place.
Device: Cardiac pacing - Leadless pacing
Implantation of devices for cardiac pacing/defibrillation
Also known as: Cardiac defibrillation - Conventional RV pacing
Implantation of devices for cardiac pacing/defibrillation
Also known as: Cardiac defibrillation - Conduction System Pacing
Implantation of devices for cardiac pacing/defibrillation
Also known as: Cardiac defibrillation - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
Implantation of devices for cardiac pacing/defibrillation
Also known as: Cardiac defibrillation - Epicardial pacing
Implantation of devices for cardiac pacing/defibrillation
Also known as: Cardiac defibrillation - Leadless pacing
30 days efficacy
Number of successful implantations, defined as the achievement of the planned pacing modality
Time frame: 30 days
Rate of hospitalizations for heart failure at 12 months
The investigators considered the worsening of heart failure requiring hospital management
Time frame: 12 months
All cause death at 12 months
The investigators will monitor patient's all causes death
Time frame: 12 months
All cause and cardiovascular death at 1, 3, 5, 10 years
The investigators will monitor patient's all causes and cardiovascular death
Time frame: 120 months
Onset/worsening of heart failure
The investigators will assess patient's hemodynamic stability over the years, monitoring the onset or the worsening of heart failure
Time frame: 120 months
Onset/worsening of atrial tachyarrhythmias
The investigators will monitor patient's rhythm over the years, assessing the onset or the worsening of atrial tachyarrhythmias.
Time frame: 120 months
Onset/worsening of ventricular tachyarrhythmias
The investigators will monitor patient's rhythm over the years, assessing the onset or the worsening of ventricular tachyarrhythmias.
Time frame: 120 months
Procedural time
The investigators will evaluate procedural time of different cardiac pacing modalities
Time frame: implantation procedure
Fluoroscopy time
The investigators will evaluate fluoroscopy time of different cardiac pacing modalities
Time frame: implantation procedure
Radiation exposure
The investigators will evaluate radiation exposure of different cardiac pacing modalities monitoring the dose area product
Time frame: implantation procedure
Success rate of CRT in heart failure
The investigators consider successful CRT if obtain a left ventricular end-systolic volume reduction \>15%
Time frame: 120 months
Cardiac perforation rate
The investigators will evaluate how often cardiac perforation occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 30 days
Hemothorax rate
The investigators will evaluate how often hemothorax occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 30 days
Pneumothorax rate
The investigators will evaluate how often pneumothorax occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 30 days
Pocket hematoma rate
The investigators will evaluate how often pocket hematoma occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 30 days
Pericardial effusion rate
The investigators will evaluate how often pericardial effusion occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 30 days
Lead dislocation rate
The investigators will evaluate how often catheter dislocation occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 120 months
Lead fracture rate
The investigators will evaluate how often catheter rupture occurs in relation to the total number of implants and in the various pacing modalities
Time frame: 120 months
Cardiac Implantable Electronic Devices infections rate
The investigators will evaluate how often infections occur in relation to the total number of implants and in the various pacing modalities
Time frame: 120 months
Reintervention rate
The investigators will evaluate how often reintervention is needed in relation to the total number of implants and in the various pacing modalities
Time frame: 120 months
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