Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324682
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-01-31
Brief Title:
ConTempoRary Cardiac Stimulation in Clinical practicE lEft BivEntriculAr Right and conDuction System Pacing
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE lEft BivEntriculAr Right and conDuction System Pacing
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREEBEARD
Brief Summary:
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 pacemakerintracardiac 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
Participants patients over 18 years old with an indication to receive a definitive pacemakerintracardiac 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
Detailed Description:
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
Endocardial right chambers pacing the device is implanted in the subcutaneous subclavian area and it is connected to transvenous leads implanted in the right cardiac chambers which detect intrinsic electrical activity and stimulate when needed
Epicardial pacing this procedure is often performed in conjunction with cardiac surgery
Cardiac resynchronisation therapy CRT it delivers biventricular or left ventricular pacing in order to correct interventricular electromechanical dyssynchrony and to improve cardiac output
Conduction system pacing it stimulates the His bundle or the left bundle branch area downstream of the conduction block in order to restore a physiological electromechanical activation
Leadless pacing via a percutaneous approach through a large-calibre vein leadless device is placed inside the right ventricle
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 improvementonset 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 difficultiesabsence 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
1 Right chambers endocardial pacing
2 Cardiac resynchronisation therapy
3 Conduction system pacing
1 His bundle pacing
2 Left bundle branch area pacing In addition the efficacy and safety at 30 days and the efficacy and safety at 6 and 12 months of the various pacing modalities will be evaluated
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 2grdl 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
Nowadays five types of cardiac pacing are recognised in clinical practice
Endocardial right chambers pacing the device is implanted in the subcutaneous subclavian area and it is connected to transvenous leads implanted in the right cardiac chambers which detect intrinsic electrical activity and stimulate when needed
Epicardial pacing this procedure is often performed in conjunction with cardiac surgery
Cardiac resynchronisation therapy CRT it delivers biventricular or left ventricular pacing in order to correct interventricular electromechanical dyssynchrony and to improve cardiac output
Conduction system pacing it stimulates the His bundle or the left bundle branch area downstream of the conduction block in order to restore a physiological electromechanical activation
Leadless pacing via a percutaneous approach through a large-calibre vein leadless device is placed inside the right ventricle
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 improvementonset 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 difficultiesabsence 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
1 Right chambers endocardial pacing
2 Cardiac resynchronisation therapy
3 Conduction system pacing
1 His bundle pacing
2 Left bundle branch area pacing In addition the efficacy and safety at 30 days and the efficacy and safety at 6 and 12 months of the various pacing modalities will be evaluated
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 2grdl 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None