Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored

• Conditions: Pacemaker; Defibrillators, Implantable; Heart Failure With Reduced Ejection Fraction; Arrythmia

• Registration Number: NCT03061747
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

Brief Summary

Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-02-18
• Last Update Submitted: 2017-02-18
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-04-15
• Study Completion: 2017-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• ICD of pacemaker implantation fo any indication
• Followed by remote monitoring
• Age >18 years

Exclusion Criteria

• life expectancy of less than one year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death for any cause	an average of 2 years

Secondary Outcome Measures

Name	Time	Method
Atrial arrhythmias	an average of 2 years
Hospitalizations for any cause	an average of 2 years

Trial Locations

Locations (6)

University Hospital "Umberto I - Lancisi - Salesi"; 🇮🇹 Ancona, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

AO Pugliese-Ciaccio; 🇮🇹 Catanzaro, Italy

Vito Fazzi Hospital; 🇮🇹 Lecce, Italy

Monaldi Hospital; 🇮🇹 Napoli, Italy

Dell'Era Gabriele; 🇮🇹 Novara, Italy