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 \[patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant\] 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

8,400

participants targeted

Target at P75+ for all trials

Timeline

105mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach

1 country

31 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 years study duration

Study Progress28%

Jan 2023Dec 2034

Study Start

First participant enrolled

January 1, 2023

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed

2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed

9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

11 years

First QC Date

January 31, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

Pace maker (PM)Implantable cardioverter defibrillator (ICD)Atrioventricular BlockBradyarrhythmiaVentricular DysfunctionCardiac Resynchronization therapyConduction System PacingHis PacingLeft bundle branch area pacing (LBBAP)CRTCSPPrimary preventionSecondary preventionAtrioventricular Block CompleteHeart failureVentricular ArrythmiaVentricular FibrillationVentricular Tachycardia

Outcome Measures

Primary Outcomes (3)

30 days efficacy
Number of successful implantations, defined as the achievement of the planned pacing modality
30 days
Rate of hospitalizations for heart failure at 12 months
The investigators considered the worsening of heart failure requiring hospital management
12 months
All cause death at 12 months
The investigators will monitor patient's all causes death
12 months

Secondary Outcomes (17)

All cause and cardiovascular death at 1, 3, 5, 10 years
120 months
Onset/worsening of heart failure
120 months
Onset/worsening of atrial tachyarrhythmias
120 months
Onset/worsening of ventricular tachyarrhythmias
120 months
Procedural time
implantation procedure
+12 more secondary outcomes

Study Arms (5)

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.

Device: Cardiac pacing - Conventional RV pacing

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.

Device: Cardiac pacing - Conduction System Pacing

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.

Device: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)

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.

Device: Cardiac pacing - Epicardial pacing

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.

Device: Cardiac pacing - Leadless pacing