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ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing

ConditionsArrhythmias, CardiacAtrioventricular BlockReduced Systolic FunctionAtrial FibrillationBradyarrhythmiaVentricular TachycardiaVentricular DysfunctionVentricular FibrillationVentricular ArrythmiaAtrioventricular Nodal DiseaseAtrioventricular Conduction DefectsAtrioventricular Block CompleteAtrioventricular Block IncompleteAtrioventricular Junctional RhythmBundle-Branch BlockLeft Bundle-Branch BlockHeart Failure, SystolicBlock;AtrioventricularBlock; ArrhythmicBlock; MobitzBlock, HeartBlock, FascicularBlock Branch Bundle LeftHeart Failure，CongestiveHeart Arrhythmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Ferrara

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Indication for cardiac stimulation

Having performed the implantation of a device for cardiac stimulation

Disqualifiers

Age < 18 years;

Pregnancy status;

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac pacing - Conventional RV pacing

    Device

    Implantation of devices for cardiac pacing/defibrillation

  • Cardiac pacing - Conduction System Pacing

    Device

    Implantation of devices for cardiac pacing/defibrillation

  • Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)

    Device

    Implantation of devices for cardiac pacing/defibrillation

  • Cardiac pacing - Epicardial pacing

    Device

    Implantation of devices for cardiac pacing/defibrillation

  • Cardiac pacing - Leadless pacing

    Device

    Implantation of devices for cardiac pacing/defibrillation

Treatment groups

8,400 Participants
are divided into 5 treatment groups
Group A: Conventional right ventricular (RV) pacing1 intervention
Group B: Conduction System Pacing1 intervention
Group C: Cardiac resynchronization therapy (CRT) either -pacing (CRTP) or -defibrillation (CRTD)1 intervention
Group D: Epicardial pacing1 intervention
Group E: Leadless pacing1 intervention

Trial outcomes

Primary outcomes

1

30 days efficacy

Number of successful implantations, defined as the achievement of the planned pacing modality

Time frame
30 days
2

Rate of hospitalizations for heart failure at 12 months

The investigators considered the worsening of heart failure requiring hospital management

Time frame
12 months
3

All cause death at 12 months

The investigators will monitor patient's all causes death

Time frame
12 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Ferrara

Lead sponsor

Source ClinicalTrials.gov
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