NCT03125382

Brief Summary

Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

April 1, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

February 5, 2024

Completed
Last Updated

July 2, 2025

Status Verified

May 1, 2023

Enrollment Period

4.5 years

First QC Date

May 25, 2016

Results QC Date

February 22, 2018

Last Update Submit

June 30, 2025

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Number of Patient Satisfied or Very Satisfied With Carelink

    through the semi-quantitative evaluation of patient satisfaction with Carelink System and their preference when compared to traditional in-clinic follow-up, the options were: 1) Very Satisfied; 2) Satisfied; 3) Not Satisfied nether Unsatisfied; 4) Unsatisfied; 5)Very Unsatisfied

    12 months visit

Secondary Outcomes (7)

  • Number of Device Related Adverse Events

    12 months visit

  • Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings

    12 months visit

  • Health Care Consumed Resources Between Groups Relative to Unscheduled Visits

    12 months visit

  • Compare Patient Consumed Resources Between Groups

    Baseline

  • Compare Patient Consumed Resources Between Groups

    Baseline

  • +2 more secondary outcomes

Study Arms (4)

In office standard visit-New

ACTIVE COMPARATOR

Patients with new implants who do not perform device data transmission through Carelink system

Device: In office standard visit

In office standard visit-Previous

ACTIVE COMPARATOR

Patients with previous implants who do not perform device data transmission through Carelink system

Device: In office standard visit

Carelink - New Implants

EXPERIMENTAL

Patients with new implants who perform device data transmission through Carelink system

Device: Carelink System

Carelink - Previous Implants

EXPERIMENTAL

Patients with previous implants who perform device data transmission through Carelink system

Device: Carelink System

Interventions

Carelink SystemDEVICE

Patients start to perform device data transmission through Carelink system

Carelink - New ImplantsCarelink - Previous Implants
In office standard visitDEVICE

Patients start or maintain in office standard visits

In office standard visit-NewIn office standard visit-Previous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D (Cardiac Resynchronization Therapy - Defibrillator), ICD
  • Subject or the subject's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant to perform those studies
  • Subject has signed a Patient Informed Consent Form from this study

You may not qualify if:

  • Subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available)
  • Subject is less than 18 years of age
  • Subject is enrolled or intends to participate in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Hospitalar do Algarve

Faro, 8000-386, Portugal

Location

Centro Hospitalar de Alto Ave - Unidade de Guimarães

Guimarães, 4835-044, Portugal

Location

Centro Hospitalar Lisboa Central- Hospital de Santa Marta

Lisbon, 1169-1024, Portugal

Location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Centro Hospitalar de Setúbal

Setúbal, 2910 - 446, Portugal

Location

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4434-502, Portugal

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Drª. Milene Fernandes
Organization
IMP
milenefernandes@hotmail.com
00351965751328

Study Officials

  • Mário Oliveira, Doctor

    Centro Hospitalar Lisboa Central

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

April 24, 2017

Study Start

April 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 2, 2025

Results First Posted

February 5, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PT(6)