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

April 12, 2016 updated by: Pietro Palmisano, Azienda Ospedaliera Cardinale G. Panico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • University Hospital "Umberto I - Lancisi - Salesi"
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S.Orsola-Malpighi
      • Catanzaro, Italy, 88100
        • Recruiting
        • AO Pugliese-Ciaccio
      • Novara, Italy
        • Recruiting
        • Ospedale Maggiore della Carita
      • Roma, Italy, 00135
        • Recruiting
        • Ospedale San Filippo Neri
        • Contact:
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Recruiting
        • "Card. G. Panico" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients underwent ICD implantation from January 2010 to December 2012 for any indication at enrolling hospitals

Description

Inclusion Criteria:

  • ICD implantation fo any indication;
  • age >18 years

Exclusion Criteria:

  • life expectancy of less than one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death for any cause
Time Frame: an average of 2 years
an average of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications related to ICD implantation
Time Frame: an average of 2 years
an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Cardinale G. Panico

Investigators

  • Principal Investigator: Pietro Palmisano, MD, Cardiology Unit - "Card. G. Panico" Hospital - Tricase

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

April 2, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (ESTIMATE)

April 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBSERVO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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