Arrhythmias Detection in a Real World Population

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Oct 23, 2014

Keywords

ClinConnect Summary

This clinical trial is studying how well implantable cardioverter defibrillators (ICDs)—devices that help control abnormal heart rhythms—work in real-life patients. The main goal is to find out what factors predict when the device gives a shock to correct a fast heartbeat that needs treatment. The study will also look at how often these shocks happen, when the device might give unnecessary shocks, and how well doctors follow current treatment guidelines in Italy. Additionally, researchers want to understand what might lead to heart failure and how patients respond to a special type of therapy called cardiac resynchronization therapy (CRT), which helps the heart beat more efficiently.

People who may join this study include those who have recently had an ICD implanted, replaced, or upgraded—whether it’s a single-chamber, dual-chamber, or CRT defibrillator. To participate, patients must be willing to share their health information, give consent, and be able to attend follow-up visits for at least one year. Pregnant women or those in other conflicting studies cannot join. Participants can expect regular check-ups during the study to monitor their heart and device performance. This study is currently recruiting patients and aims to help improve how ICDs are used and managed in everyday medical care.

Gender

ALL

Eligibility 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