Real-world monitoring of arrhythmias and ICD shock therapy
Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 12 sites (Bergamo and 11 other locations) |
| Trial ID | NCT02275637 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bergamo and 11 other locations
- 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)
- 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 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.