Evaluating different approaches to cardiac pacing in patients
Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
This study is testing different ways to place pacemakers in adults to see which methods work best and are safest for patients needing heart support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 31 sites (Ferrara, FE and 30 other locations) |
| Trial ID | NCT06324682 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical characteristics of patients receiving permanent cardiac pacing and to compare the efficacy and safety of various implantation techniques. Participants over 18 years old with an indication for a pacemaker or intracardiac defibrillator will be included, and the study will evaluate the contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems during the procedures. The study focuses on multiple pacing modalities, including endocardial, epicardial, cardiac resynchronization therapy, conduction system pacing, and leadless pacing.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require a definitive pacemaker or intracardiac defibrillator implant.
Not a fit: Patients under 18 years old or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cardiac pacing techniques, leading to improved patient outcomes and quality of life.
How similar studies have performed: Other studies have shown success with various cardiac pacing approaches, but this study aims to provide a comprehensive comparison of multiple techniques in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for cardiac stimulation * Having performed the implantation of a device for cardiac stimulation Exclusion Criteria: * Age \< 18 years; * Pregnancy status;
Where this trial is running
Ferrara, FE and 30 other locations
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Fe, Italy (Recruiting)
- Ospedale San Donato — Arezzo, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna — Bologna, Italy (Recruiting)
- spedale Maggiore di Bologna — Bologna, Italy (Recruiting)
- Ospedale Bernardino Ramazzini — Carpi, Italy (Recruiting)
- Ospedale SS Annunziata — Cento, Italy (Recruiting)
- Ospedale Bufalini — Cesena, Italy (Recruiting)
- Ospedale San Giuseppe — Empoli, Italy (Recruiting)
- Ospedale di Vaio — Fidenza, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (Recruiting)
- Ospedale San Giovanni di Dio — Florence, Italy (Recruiting)
- Ospedale Santa Maria Annunziata Bagno a Ripoli — Florence, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria "Ospedali Riuniti" — Foggia, Italy (Recruiting)
- Ospedale Morgagni-Pierantoni — Forlì, Italy (Recruiting)
- Ospedale Santa Maria della Misericordia Grosseto — Grosseto, Italy (Recruiting)
- Ospedale della Versilia — Lido di Camaiore, Italy (Recruiting)
- Ospedali Riuniti di Livorno — Livorno, Italy (Recruiting)
- Ospedale San Luca — Lucca, Italy (Recruiting)
- Nuovo ospedale Apuano Massa — Massa, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Policlinico di Modena — Modena, Italy (Recruiting)
- Ospedale Sant'Agostino Estense Modena Baggiovara — Modena, Italy (Recruiting)
- Ospedale Civico, azienda Ospedaliera di Palermo — Palermo, Italy (Recruiting)
- Policlinico Paolo Giaccone — Palermo, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Maggiore — Parma, Italy (Recruiting)
- Ospedale Guglielmo da Saliceto Piacenza — Piacenza, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria pisana Cisanello — Pisa, Italy (Recruiting)
- Fondazione Toscana Gabriele Monasterio — Pisa, Italy (Recruiting)
- Ospedale Santa Maria delle Croci — Ravenna, Italy (Recruiting)
- ASMN Reggio Emilia — Reggio Emilia, Italy (Recruiting)
- Ospedale degli Infermi Rimini — Rimini, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Senese — Siena, Italy (Recruiting)
Study contacts
- Principal investigator: Matteo Bertini, MD, PhD — Azienda Ospedaliero Universitaria di Ferrara
- Study coordinator: Matteo Bertini, MD, PhD
- Email: brtmtt2@unife.it
- Phone: +390532236269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.