Cost-utility Analysis of the Follow-up of Exclusive Telemedicine Pacemakers, Compared to Conventional Pacemakers

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.

Conditions

• Single or Dual Chamber Pacemaker Implantation
• Home Monitoring Follow-up

Interventions

OTHER

Follow up post Pacemaker implantation in office

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

OTHER

Follow up post Pacemaker implantation by home monitoring

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

Sponsors & Collaborators

• Tours University Hospital

  collaborator UNKNOWN

• University Hospital, Marseille

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Angers University Hospital

  collaborator UNKNOWN

• Lille University Hospital

  collaborator UNKNOWN

• University Hospital, Strasbourg, France

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• Montpellier University Hospital

  collaborator UNKNOWN

• University Hospital, Brest

  collaborator OTHER

• Pau University Hospital

  collaborator UNKNOWN

• Nantes University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-04

Primary Completion

2025-05-05

Completion

2025-05-05

Countries

• France

Study Locations