Real-world monitoring of arrhythmias and ICD shock therapy
Official title: Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT02275637 · Data updated 2026-11-12
This registry will follow people getting an implantable cardioverter‑defibrillator to see which patients receive appropriate or inappropriate shocks and why.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 12 sites (Bergamo and 11 other locations) |
| Status | Recruiting |
| Started | September 2014 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | July 8, 2025 |
| Trial ID | NCT02275637 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults scheduled for ICD implant, replacement, or upgrade who can give consent and attend follow‑up visits at a participating Italian center for at least 12 months.
✕Probably not a fit
Patients without an ICD indication, those unable to attend follow‑up visits, pregnant women, or people enrolled in other conflicting trials are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter registry enrolling consecutive patients receiving initial implant, replacement, or upgrade of an implantable cardioverter‑defibrillator (including single‑ and dual‑chamber, subcutaneous, and CRT‑D systems) at several Italian centers. Participants will be followed for at least 12 months with routine device interrogations and clinical visits to record episodes of ventricular tachycardia/fibrillation and any delivered anti‑tachycardia therapies. The primary aim is to identify predictors of appropriate shock therapy in an unselected ICD population; secondary aims include measuring incidence of therapies, predictors of inappropriate shocks and arrhythmia burden, adherence to Italian guideline recommendations, and predictors of heart failure onset and response to CRT. Data will be entered prospectively into a registry database and analyzed to identify clinical and device-related risk factors.
Why it matters
Potential benefit: If successful, the registry could help clinicians better predict who will benefit from ICD shocks and reduce inappropriate therapies.
How similar studies have gone: Large ICD registries and randomized trials have previously identified predictors of appropriate and inappropriate ICD therapies, so this registry builds on established evidence while focusing on real‑world Italian practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient implanted with a Subcutaneous (S)- Ventricular Chamber (VR)- Dual Chamber (DR) - or Cardiac Resynchronization Therapy (CRT) Defibrillator (this study will utilize all the market released CRT-D or VR/DR-ICD systems and leads) * Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent * Patient must be able to attend all required follow-up visits at the study center for at least 12 months Exclusion Criteria: * Patient is participating in another clinical study that may have an impact on the study endpoints * Women who are pregnant or plan to become pregnant
Where it's running
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Ospedale Papa Giovanni XXIII
Bergamo, Italy Recruiting -
Policlinico S.Orsola-Malpighi
Bologna, Italy Recruiting -
P.O. Rodolico-San Marco
Catania, Italy Recruiting -
Azienda Ospedaliero Universitaria Careggi
Florence, Italy Recruiting -
ASST Rhodense- Ospedale di Rho
Milan, Italy Recruiting -
IRCCS S.Ambrogio-Galeazzi
Milan, Italy Recruiting
Show 6 more locations
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Ospedale dei Colli Monaldi
Naples, Italy Recruiting -
University of Padua
Padua, Italy Recruiting -
IRCC Policlinico San Matteo
Pavia, Italy Recruiting -
Azienda Ospedaliero Universitaria Pisa Cisanello
Pisa, Italy Recruiting -
Azienda Ospedaliera S.Andrea
Rome, Italy Recruiting -
Ospedale Bambino Gesù
Rome, Italy Recruiting
Study contacts
- Study coordinator: Alessandro Vicentini, MD
- Email: clinical-estimate@isis.it
- Phone: 0382.503715
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.