NCT03813589

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 19, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

January 20, 2019

Last Update Submit

March 24, 2021

Conditions

Heart Failure，CongestiveAtrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Evaluate relationship between atrial tachyarrhythmias and congestive heart failure

    Relationship between thoracic impedance variations and atrial events collected by device

    twelve months

Secondary Outcomes (1)

  • Detect optimal device programming

    twelve months

Study Arms (1)

PMK patients

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Leonardo Hospital

Castellammare di Stabia, Napoli, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Giovanni Russo, MD

    San Leonardo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 20, 2019

First Posted

January 23, 2019

Study Start

January 19, 2019

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations

IT(1)