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Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator

NCT03876600 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2019-03-15

No results posted yet for this study

Summary

START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care.

The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce hospitalization and care expenses without loss of quality of care and without increasing the complication rate for patients.

Conditions

  • Pacemaker Ddd

Interventions

PROCEDURE

Replacement of permanent pacemakers for elective wear.

START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms. The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Vincent Probst · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876600 on ClinicalTrials.gov