CClinicalTrials.gg
Status unknownNCT03813589SEASIDEUpdated Mar 25, 2021

Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients

An observational study in Heart Failure,Congestive and Atrial Arrhythmia, sponsored by San Leonardo Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-25.

Sponsored by San Leonardo Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure,Congestive
  • Atrial Arrhythmia
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

This is the only study on the registry with San Leonardo Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • PMK patients

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

06

What researchers measure

Primary outcomes

  1. Evaluate relationship between atrial tachyarrhythmias and congestive heart failure

    Relationship between thoracic impedance variations and atrial events collected by device

    Time frame: twelve months

Secondary outcomes

  1. Detect optimal device programming

    Identify useful index congestion trigger value

    Time frame: twelve months

07

Study locations

1 site
  • San Leonardo Hospital
    Castellammare Di Stabia, Napoli, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03813589
Lead sponsor
San Leonardo Hospital
Responsible party
Giovanni Russo (MD, San Leonardo Hospital) — Principal investigator
First posted
Jan 23, 2019
Start date
Jan 19, 2019
Primary completion
Jan 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Mar 25, 2021

Study contacts

Giovanni Russo, MD
principal investigator · San Leonardo Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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