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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04761315
Other study ID # TFM 2016-18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2016

Study information

Verified date February 2021
Source Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.


Description:

The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 380
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patients in sinus rhythm - with or without previous paroxysmal AF - with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT) - capable of atrial activity monitoring were included in the study Exclusion Criteria: -Previous documented atrial fibrillation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial high rate new episodes New episodes of atrial high rate episodes 24 months
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