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

Locations
Other Locations
Italy
Ospedale San Donato
RECRUITING
Arezzo
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna
RECRUITING
Bologna
spedale Maggiore di Bologna
RECRUITING
Bologna
Ospedale Bernardino Ramazzini
RECRUITING
Carpi
Ospedale SS Annunziata
RECRUITING
Cento
Ospedale Bufalini
RECRUITING
Cesena
Ospedale San Giuseppe
RECRUITING
Empoli
Azienda Ospedaliero-Universitaria di Ferrara
RECRUITING
Ferrara
Ospedale di Vaio
RECRUITING
Fidenza
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Ospedale San Giovanni di Dio
RECRUITING
Florence
Ospedale Santa Maria Annunziata Bagno a Ripoli
RECRUITING
Florence
Azienda Ospedaliero-Universitaria Ospedali Riuniti
RECRUITING
Foggia
Ospedale Morgagni-Pierantoni
RECRUITING
Forlì
Ospedale Santa Maria della Misericordia Grosseto
RECRUITING
Grosseto
Ospedale della Versilia
RECRUITING
Lido Di Camaiore
Ospedali Riuniti di Livorno
RECRUITING
Livorno
Ospedale San Luca
RECRUITING
Lucca
Nuovo ospedale Apuano Massa
RECRUITING
Massa
Azienda Ospedaliero-Universitaria Policlinico di Modena
RECRUITING
Modena
Ospedale Sant'Agostino Estense Modena Baggiovara
RECRUITING
Modena
Ospedale Civico, azienda Ospedaliera di Palermo
RECRUITING
Palermo
Policlinico Paolo Giaccone
RECRUITING
Palermo
Azienda Ospedaliero-Universitaria Maggiore
RECRUITING
Parma
Ospedale Guglielmo da Saliceto Piacenza
RECRUITING
Piacenza
Azienda Ospedaliero-Universitaria pisana Cisanello
RECRUITING
Pisa
Fondazione Toscana Gabriele Monasterio
RECRUITING
Pisa
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
ASMN Reggio Emilia
RECRUITING
Reggio Emilia
Ospedale degli Infermi Rimini
RECRUITING
Rimini
Azienda Ospedaliero-Universitaria Senese
RECRUITING
Siena
Contact Information
Primary
Matteo Bertini, MD, PhD
brtmtt2@unife.it
+390532236269
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 8400
Treatments
Conventional right ventricular (RV) pacing
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.
Sponsors
Leads: University Hospital of Ferrara

This content was sourced from clinicaltrials.gov