NCT04148703

Brief Summary

TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Patient will be randomized in a control group followed according to the current guidelines and and active group exclusively followed by remote monitoring. The study will end after a 4 year 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
620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5.5 years

First QC Date

October 24, 2019

Last Update Submit

June 5, 2023

Conditions

Single or Dual Chamber Pacemaker ImplantationHome Monitoring Follow-up

Keywords

Pacemaker, home monitoring, remote monitoring, ecocomic

Outcome Measures

Primary Outcomes (2)

  • ICER (incremental cost effectivness ratio)

    cost and medical consumtion collected with the French insurance care database

    4 years

  • QALY

    Quality Adjusted Life Years estimated by EQ5D-5L

    4 years

Secondary Outcomes (2)

  • Safety of home monitoring

    4 years

  • Safety of home monitoring

    4 years

Study Arms (2)

Active group

EXPERIMENTAL

in-office follow-up at 30 days post-implantation and after by remote monitoring (daily) without scheduled in-office follow-up during the study period (48 months). A remote FU will be planned every 9 months.

Other: Follow up post Pacemaker implantation by home monitoring

Control group

ACTIVE COMPARATOR

The patients randomized in the control group will be followed accordingto the guidelines; i.e. with an in-office follow-up at 30 days post-implantation and after followed with in-office follow-ups according to clinical practice.

Other: Follow up post Pacemaker implantation in office

Interventions

Follow up post Pacemaker implantation in officeOTHER

All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by in-office follow-up

Control group
Follow up post Pacemaker implantation by home monitoringOTHER

All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by home monitoring

Active group

Eligibility Criteria

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

You may qualify if:

  • Single or dual chamber pacemaker implantation patients
  • patients agree to be enrolled in the study and followed during 4 years
  • patients have insurance coverage

You may not qualify if:

  • Minor patients
  • personn with disability
  • pregnant women
  • patient with life expectancy of less than 4 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GOURAUD Jean-Baptiste

Nantes, 44000, France

Location

MeSH Terms

Interventions

Working Conditions

Intervention Hierarchy (Ancestors)

WorkplaceEmploymentSocioeconomic FactorsPopulation CharacteristicsPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Design

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

Study Record Dates

First Submitted

October 24, 2019

First Posted

November 1, 2019

Study Start

November 4, 2019

Primary Completion

May 5, 2025

Study Completion

May 5, 2025

Last Updated

June 6, 2023

Record last verified: 2023-05

Locations

FR(1)