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

Status: Unknown status
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Man or woman over 18 years old.

• Replacement of permanent pacemakers for battery elective wear without programmed act in the sensors regardless of pacemaker type, simple, dual or triple chambers and regardless pacemaker label.

• Patient living less than an hour from a hospital center

• Patient is able to answer the phone.

• Patient has an accompaniment the go out night

• Pacemaker-dependent patient or not regardless of indication of placement of the pacemaker

• Patient with or without anticoagulant treatment: the anticoagulant treatment is managed by center under these habits.

• Patient has given this free and informed consent.

• Patient having insurance in France.

Locations
Other Locations
France
Angers University Hospital
Angers
Brest University Hospital
Brest
Dijon University Hospital
Dijon
Grenoble University Hospital
Grenoble
Lyon University Hospital
Lyon
AP-HM
Marseille
Montpellier University Hospital
Montpellier
Nancy University Hospital
Nancy
AP-HP, La Pitié Salpétrière
Paris
Rennes University Hospital
Rennes
Saint-Etienne University Hospital
Saint-étienne
Strasbourg University Hospital
Strasbourg
Toulouse University Hospital
Toulouse
Tours University Hopsital
Tours
Contact Information
Primary
Vincent Probst
vincent.probst@chu-nantes.fr
0240165093
Backup
Imen Fellah
imen.fellah@chu-nantes.fr
0240165102
Time Frame
Start Date: April 2019
Completion Date: April 2022
Participants
Target number of participants: 750
Treatments
Experimental: conventional hospitalization management.
The patients who are randomized to have a conventional hospitalization for the pacemaker replacement have conventional management.~In this management patient come to hospital one day before this surgical operation and he is operated next day
Active Comparator: ambulatory management
The patients who are randomized to have a ambulatory surgery for the pacemaker replacement have ambulatory management.~In the ambulatory hospitalization patients come to hospital and have a surgical operation the same day
Sponsors
Leads: Nantes University Hospital
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov

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