Status:
UNKNOWN
Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Pacemaker Ddd
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
In France, nearly 49,000 permanent pacemakers are implanted each year. The pacemaker longevity is about 10 years which leads to their replacement. In France, in 2016, 15,764 pacemaker replacement hos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Ambulatory Hospitalization is impossible.
- Patient refuses to participate
- Patient has hemostasis disorder yielding ambulatory hospitalization impossible.
- Woman is pregnant, nursing mothers or the patient don't receive an effective contraception.
- Patient under guardianship, safeguard of justice
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT03876600
Start Date
April 1 2019
End Date
April 1 2022
Last Update
March 15 2019
Active Locations (14)
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1
Lyon University Hospital
Lyon, Bron, France, 69677
2
Angers University Hospital
Angers, France, 49933
3
Brest University Hospital
Brest, France, 29200
4
Dijon University Hospital
Dijon, France, 21079