Actively Recruiting

Age: 18Years +
All Genders
ID06324682

Evaluation of Contemporary Cardiac Stimulation in Clinical Practice: Left, Biventricular, Right, and Conduction System Pacing

Led by University Hospital of Ferrara · Updated on 2024-03-22

8400

Participants Needed

31

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches: conventional right ventricular pacing, conduction system pacing (such as His bundle or left bundle branch area pacing), cardiac resynchronization therapy (CRT) with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for cardiac stimulation
  • Having performed the implantation of a device for cardiac stimulation
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Pregnancy status

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Implantation procedure day

Participants undergo implantation of a cardiac pacing device using one of several approaches, including conventional right ventricular pacing, conduction system pacing, cardiac resynchronization therapy, epicardial pacing, or leadless pacing.

1 visit (in-person) for device implantation

Monitoring

Duration - 30 days

Participants are monitored for device efficacy and safety, including stable electrical parameters, absence of cardiovascular hospitalizations and death, and procedural complications within 30 days post-implantation.

1 to 2 visits within 30 days

Long-term Monitoring

Duration - Up to 120 months

Participants are followed for up to 120 months to assess long-term efficacy and safety of the cardiac pacing device, including heart failure onset or worsening, arrhythmias, device function, infections, and need for re-intervention.

Periodic visits as per clinical practice over 10 years

Trial Site Locations

Total: 31 locations

1

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, FE, Italy, 44124

Actively Recruiting

2

Ospedale San Donato

Arezzo, Italy

Actively Recruiting

3

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna

Bologna, Italy, 40138

Actively Recruiting

4

spedale Maggiore di Bologna

Bologna, Italy

Actively Recruiting

5

Ospedale Bernardino Ramazzini

Carpi, Italy

Actively Recruiting

6

Ospedale SS Annunziata

Cento, Italy

Actively Recruiting

7

Ospedale Bufalini

Cesena, Italy

Actively Recruiting

8

Ospedale San Giuseppe

Empoli, Italy

Actively Recruiting

9

Ospedale di Vaio

Fidenza, Italy

Actively Recruiting

10

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Actively Recruiting

11

Ospedale San Giovanni di Dio

Florence, Italy

Actively Recruiting

12

Ospedale Santa Maria Annunziata Bagno a Ripoli

Florence, Italy

Actively Recruiting

13

Azienda Ospedaliero-Universitaria "Ospedali Riuniti"

Foggia, Italy

Actively Recruiting

14

Ospedale Morgagni-Pierantoni

Forlì, Italy

Actively Recruiting

15

Ospedale Santa Maria della Misericordia Grosseto

Grosseto, Italy

Actively Recruiting

16

Ospedale della Versilia

Lido di Camaiore, Italy

Actively Recruiting

17

Ospedali Riuniti di Livorno

Livorno, Italy

Actively Recruiting

18

Ospedale San Luca

Lucca, Italy

Actively Recruiting

19

Nuovo ospedale Apuano Massa

Massa, Italy

Actively Recruiting

20

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Italy

Actively Recruiting

21

Ospedale Sant'Agostino Estense Modena Baggiovara

Modena, Italy

Actively Recruiting

22

Ospedale Civico, azienda Ospedaliera di Palermo

Palermo, Italy

Actively Recruiting

23

Policlinico Paolo Giaccone

Palermo, Italy

Actively Recruiting

24

Azienda Ospedaliero-Universitaria Maggiore

Parma, Italy

Actively Recruiting

25

Ospedale Guglielmo da Saliceto Piacenza

Piacenza, Italy, 29100

Actively Recruiting

26

Azienda Ospedaliero-Universitaria pisana Cisanello

Pisa, Italy

Actively Recruiting

27

Fondazione Toscana Gabriele Monasterio

Pisa, Italy

Actively Recruiting

28

Ospedale Santa Maria delle Croci

Ravenna, Italy

Actively Recruiting

29

ASMN Reggio Emilia

Reggio Emilia, Italy

Actively Recruiting

30

Ospedale degli Infermi Rimini

Rimini, Italy

Actively Recruiting

31

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

Actively Recruiting

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Research Team

M

Matteo Bertini, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

Two-year outcomes of left bundle branch area pacing versus traditional right ventricular pacing in middle-aged adults: a registry-based trial.

Matteo Bertini, Luca Canovi, Francesco Vitali...

https://pubmed.ncbi.nlm.nih.gov/40880214