NCT04761315

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Status
completed

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

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

November 11, 2020

Last Update Submit

February 17, 2021

Conditions

Keywords

cardiac implantable electronic devicesinteratrial blockP-wave duration

Outcome Measures

Primary Outcomes (1)

  • Atrial high rate new episodes

    New episodes of atrial high rate episodes

    24 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in sinus rhythm, with or without previous paroxysmal AF and 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

You may qualify if:

  • 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

You may not qualify if:

  • Previous documented atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationInteratrial Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2020

First Posted

February 18, 2021

Study Start

January 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 18, 2021

Record last verified: 2021-02