UnknownNot Applicable

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

France750 participantsStarted 2019-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cost-utility analysis,from the perspective of the society and a time horizon of 6 months,of ambulatory management compared to the intervention in conventional hospitalization of a replacement,for elective wear,permanent pacemakers

Timeframe: 6 month

Trial details

NCT IDNCT03876600

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04

Contact for this trial

Vincent Probst

0240165093 vincent.probst@chu-nantes.fr

View on ClinicalTrials.gov More Pacemaker Ddd trials