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PORTuguese Research on Telemonitoring With CareLink® (PORTLink) (PORTLink)

Primary Purpose

Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Carelink System
In office standard visit
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D, 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital Hospitalar do Algarve
  • Centro Hospitalar de Alto Ave - Unidade de Guimarães
  • Centro Hospitalar Lisboa Central- Hospital de Santa Marta
  • Centro Hospitalar do Porto
  • Centro Hospitalar de Setúbal
  • Centro Hospitalar Vila Nova de Gaia/Espinho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

In office standard visit-New

In office standard visit-Previous

Carelink - New Implants

Carelink - Previous Implants

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Patient satisfaction with carelink
through the semi-quantitative evaluation of patient satisfaction with CareLink System and their preference when compared to traditional in-clinic follow-up

Secondary Outcome Measures

Number of device-related adverse events and unanticipated serious adverse device effects (USADE) rate
Physician satisfaction with carelink
Through the semi-quantitative evaluation of physician satisfaction with CareLink System and their preference when compared to traditional in-clinic follow-up
Comparation of health care consumed resources between groups
Number of unscheduled visits and visit duration
Comparation of patient consumed resources between groups
Patient costs and time consuption
Quality of life
Through SF-12 and HADS

Full Information

First Posted
May 25, 2016
Last Updated
April 18, 2017
Sponsor
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03125382
Brief Title
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Acronym
PORTLink
Official Title
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac desfibrilator (ICD)
Detailed Description
The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote CID monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In office standard visit-New
Arm Type
Active Comparator
Arm Description
Patients with new implants who do not perform device data transmission through Carelink system
Arm Title
In office standard visit-Previous
Arm Type
Active Comparator
Arm Description
Patients with previous implants who do not perform device data transmission through Carelink system
Arm Title
Carelink - New Implants
Arm Type
Experimental
Arm Description
Patients with new implants who perform device data transmission through Carelink system
Arm Title
Carelink - Previous Implants
Arm Type
Experimental
Arm Description
Patients with previous implants who perform device data transmission through Carelink system
Intervention Type
Device
Intervention Name(s)
Carelink System
Intervention Description
Patients start to perform device data transmission through Carelink system
Intervention Type
Device
Intervention Name(s)
In office standard visit
Intervention Description
Patients start or mantain in office standard visits
Primary Outcome Measure Information:
Title
Patient satisfaction with carelink
Description
through the semi-quantitative evaluation of patient satisfaction with CareLink System and their preference when compared to traditional in-clinic follow-up
Time Frame
12 months after the end of recruitment
Secondary Outcome Measure Information:
Title
Number of device-related adverse events and unanticipated serious adverse device effects (USADE) rate
Time Frame
12 months after the end of recruitment
Title
Physician satisfaction with carelink
Description
Through the semi-quantitative evaluation of physician satisfaction with CareLink System and their preference when compared to traditional in-clinic follow-up
Time Frame
12 months after the end of recruitment
Title
Comparation of health care consumed resources between groups
Description
Number of unscheduled visits and visit duration
Time Frame
12 months after the end of recruitment
Title
Comparation of patient consumed resources between groups
Description
Patient costs and time consuption
Time Frame
12 months after the end of recruitment
Title
Quality of life
Description
Through SF-12 and HADS
Time Frame
12 months after the end of recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D, 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mário Oliveira, Doctor
Organizational Affiliation
Centro Hospitalar Lisboa Central
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Hospitalar do Algarve
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Centro Hospitalar de Alto Ave - Unidade de Guimarães
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Central- Hospital de Santa Marta
City
Lisboa
ZIP/Postal Code
1169-1024
Country
Portugal
Facility Name
Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de Setúbal
City
Setúbal
ZIP/Postal Code
2910 - 446
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

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