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NCT03813589 Clinical Trial

Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients

Heart Failure,Congestive Clinical Trial

— SEASIDE  

Official title:
State of congEstive heArt Failure Before the onSet of atrIal Tachyarrhythmias Detected by Implanted devicE in Pacemaker Patients (SEASIDE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03813589
Other study ID # SS001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 19, 2019
Est. completion date June 1, 2022

Study information
Verified date March 2021
Source San Leonardo Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date June 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Recent implant of DR pacemaker according to current guidelines - Sinus Rhythm at enrollment Exclusion Criteria: - Pregnant women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy San Leonardo Hospital Castellammare Di Stabia Napoli

Sponsors (1)
Lead Sponsor Collaborator
San Leonardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate relationship between atrial tachyarrhythmias and congestive heart failure Relationship between thoracic impedance variations and atrial events collected by device twelve months
Secondary Detect optimal device programming Identify useful index congestion trigger value twelve months
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