Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Device
Study Type: Observational
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 \[patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant\] 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Indication for cardiac stimulation
• Having performed the implantation of a device for cardiac stimulation
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.
Conduction System 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.
Cardiac resynchronization therapy (CRT) either -pacing (CRTP) or -defibrillation (CRTD)
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.
Epicardial pacing
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.
Leadless 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.