Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope (SYNCOPACED)

January 12, 2020 updated by: Azienda Ospedaliera Cardinale G. Panico
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.

Study Type

Observational

Enrollment (Actual)

1364

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
        • Federico Guerra
      • Bologna, Italy, 40138
        • Policlinico S.Orsola-Malpighi
      • Catanzaro, Italy, 88100
        • AO Pugliese-Ciaccio
      • Napoli, Italy
        • Monaldi Hospital
      • Novara, Italy
        • Dell'Era Gabriele
      • Novara, Italy, 28100
        • AOU "Maggiore della Carità"
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • "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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope (proven or presumed) according current guidelines

Description

Inclusion Criteria:

  • patients undergoing pacemaker implantation for bradyarrhythmic syncope

Exclusion Criteria:

  • age <18 years

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study population
Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope
Other: Clinic follow-up
Patients are regularly evaluated to asses the occurrence of syncopal relapses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syncopal relapse
Time Frame: march 2020
First syncopal relapse after pacemaker implantation
march 2020

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Cardinale G. Panico

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)

January 1, 2010

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 12, 2020

First Submitted That Met QC Criteria

January 12, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNCOPACED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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