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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— IMPLANTED  

Official title:

Italian Multi-centre Observational Registry on Patients With impLANTable Devices Remotely monitorED

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061747
• Other study ID #: IMPLANTED
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2017
• Last updated: February 18, 2017
• Start date: June 1, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: February 2017
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: Pietro Palmisano, MD
• Phone: +390833542430
• Email: dr.palmisano[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 30, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Assesment of outcome of implantable device patients
Evaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death.

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Cardinale G. Panico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death for any cause		an average of 2 years
Secondary	Atrial arrhythmias		an average of 2 years
Secondary	Hospitalizations for any cause		an average of 2 years