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NCT04229589 Clinical Trial

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

Syncope Clinical Trial

— SYNCOPACED  

Official title:
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04229589
Other study ID # SYNCOPACED
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date May 1, 2020

Study information
Verified date December 2019
Source Azienda Ospedaliera Cardinale G. Panico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1364
Est. completion date May 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients undergoing pacemaker implantation for bradyarrhythmic syncope

Exclusion Criteria:

- age <18 years

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Clinic follow-up
Patients are regularly evaluated to asses the occurrence of syncopal relapses

Locations
Country Name City State
Italy Federico Guerra Ancona
Italy Policlinico S.Orsola-Malpighi Bologna
Italy AO Pugliese-Ciaccio Catanzaro
Italy Monaldi Hospital Napoli
Italy AOU "Maggiore della Carità" Novara
Italy Dell'Era Gabriele Novara
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 Syncopal relapse First syncopal relapse after pacemaker implantation march 2020
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