Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients (SEASIDE)

March 24, 2021 updated by: Giovanni Russo, San Leonardo Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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
    • Napoli
      • Castellammare Di Stabia, Napoli, Italy
        • San Leonardo 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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients implanted with dual chamber pacemaker able to automatically detect congestive heart failure and atrial tachyarrhythmias events.

Description

Inclusion Criteria:

  • Recent implant of DR pacemaker according to current guidelines
  • Sinus Rhythm at enrollment

Exclusion Criteria:

  • Pregnant women

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
PMK patients
Patients already implanted with double chamber pacemaker able to detect automatically congestive heart failure and collect atrial events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate relationship between atrial tachyarrhythmias and congestive heart failure
Time Frame: twelve months
Relationship between thoracic impedance variations and atrial events collected by device
twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect optimal device programming
Time Frame: twelve months
Identify useful index congestion trigger value
twelve months

Collaborators and Investigators

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

Sponsor

San Leonardo Hospital

Investigators

  • Principal Investigator: Giovanni Russo, MD, San Leonardo Hospital

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 19, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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