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

February 18, 2017 updated by: Azienda Ospedaliera Cardinale G. Panico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

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
      • Lecce, Italy
      • Napoli, Italy
      • Novara, Italy
        • Recruiting
        • Dell'Era Gabriele

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 or pacemaker implantation from January 2009 to September 2016 for any indication and followed by remote monitoring at enrolling hospitals

Description

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 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
Atrial arrhythmias
Time Frame: an average of 2 years
an average of 2 years
Hospitalizations for any cause
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, Card. G. Panico Hospital - Tricase - Italy

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 (Actual)

June 1, 2016

Primary Completion (Anticipated)

April 15, 2017

Study Completion (Anticipated)

April 30, 2017

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

February 18, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 18, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPLANTED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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