NCT03061747

Brief Summary

Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

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

June 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

February 18, 2017

Last Update Submit

February 18, 2017

Conditions

Defibrillators, ImplantableHeart Failure With Reduced Ejection FractionArrythmiaPacemaker

Outcome Measures

Primary Outcomes (1)

  • Death for any cause

    an average of 2 years

Secondary Outcomes (2)

  • Atrial arrhythmias

    an average of 2 years

  • Hospitalizations for any cause

    an average of 2 years

Interventions

Assesment of outcome of implantable device patientsDEVICE

Evaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death.

Eligibility Criteria

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

Consecutive patients underwent ICD or pacemaker implantation from January 2009 to September 2016 for any indication and followed by remote monitoring at enrolling hospitals

You may qualify if:

  • ICD of pacemaker implantation fo any indication
  • Followed by remote monitoring
  • Age \>18 years

You may not qualify if:

  • life expectancy of less than one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Policlinico S.Orsola-Malpighi

Bologna, Bologna, 40138, Italy

RECRUITING

AO Pugliese-Ciaccio

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

Dell'Era Gabriele

Novara, Novara, Italy

RECRUITING

University Hospital "Umberto I - Lancisi - Salesi"

Ancona, Italy

RECRUITING

Vito Fazzi Hospital

Lecce, Italy

RECRUITING

Monaldi Hospital

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pietro Palmisano, MD

    Card. G. Panico Hospital - Tricase - Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Palmisano, MD

CONTACT

+390833542430dr.palmisano@libero.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2017

First Posted

February 23, 2017

Study Start

June 1, 2016

Primary Completion

April 15, 2017

Study Completion

April 30, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

IT(6)