OBSERVational Registry on Long-term Outcome of ICD Patients

Cardiomyopathies Clinical Trial

— OBSERVO  

Official title:

The Italian Multicentric OBSERVational Registry on Long-term Outcome of ICD Patients (OBSERVO-ICD Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02735811
• Other study ID #: OBSERVO
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2016
• Last updated: April 12, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2016
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: Pietro Palmisano, MD
• Phone: +390833542430
• Email: dr.palmisano[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD.

Description:

Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication in the period from 2010 to 2012. The aims of the registry are to evaluate the occurrence of complications related to ICD implantation (including ICD shocks and electrical storm), and the mortality during a long-term follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICD implantation fo any indication;

• age >18 years

Exclusion Criteria:

• life expectancy of less than one year

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiomyopathies

Intervention

Device:
• Assesment of long-term outcome of ICD patients
Evaluation during follow-up of the occurrence of complications related to ICD implantation 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	Ospedale Maggiore della Carità	Novara
Italy	Ospedale San Filippo Neri	Roma
Italy	"Card. G. Panico" Hospital	Tricase	Lecce

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	Yes
Secondary	Complications related to ICD implantation		an average of 2 years	Yes