OBSERVational Registry on Long-term Outcome of ICD Patients
OBSERVO
The Italian Multicentric OBSERVational Registry on Long-term Outcome of ICD Patients (OBSERVO-ICD Registry)
1 other identifier
observational
1,300
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 2, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedApril 13, 2016
April 1, 2016
1.2 years
April 2, 2016
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death for any cause
an average of 2 years
Secondary Outcomes (1)
Complications related to ICD implantation
an average of 2 years
Interventions
Evaluation during follow-up of the occurrence of complications related to ICD implantation and of death
Eligibility Criteria
Consecutive patients underwent ICD implantation from January 2010 to December 2012 for any indication at enrolling hospitals
You may qualify if:
- ICD implantation fo any indication;
- age \>18 years
You may not qualify if:
- life expectancy of less than one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University Hospital "Umberto I - Lancisi - Salesi"
Ancona, Ancona, Italy
Policlinico S.Orsola-Malpighi
Bologna, Bologna, 40138, Italy
AO Pugliese-Ciaccio
Catanzaro, Catanzaro, 88100, Italy
"Card. G. Panico" Hospital
Tricase, Lecce, 73039, Italy
Ospedale Maggiore della Carità
Novara, Novara, Italy
Ospedale San Filippo Neri
Roma, Roma, 00135, Italy
Related Publications (1)
Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Bonelli P, Patani F, Cupido C, Devecchi C, Accogli M, Occhetta E, Santangelo L, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Implantable cardioverter-defibrillator programming and electrical storm: Results of the OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD). Heart Rhythm. 2016 Oct;13(10):1987-92. doi: 10.1016/j.hrthm.2016.06.007. Epub 2016 Jun 9.
PMID: 27291511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pietro Palmisano, MD
Cardiology Unit - "Card. G. Panico" Hospital - Tricase
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 2, 2016
First Posted
April 13, 2016
Study Start
March 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
April 13, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share