One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
OEDIPE-CRT-P
1 other identifier
observational
354
1 country
19
Brief Summary
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
December 2, 2021
CompletedStudy Start
First participant enrolled
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedDecember 26, 2025
December 1, 2025
4.2 years
October 25, 2021
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation.
Number of Serious Adverse Events
over the 6-month follow-up duration
Secondary Outcomes (12)
Duration of hospitalisation
Time between the patient's entry at the hospital and the patient's hospital discharge, an average of 2 days
Evaluation of quality of life
At baseline and 6 months of follow-up
Rate and reason for not selecting patient for a same-day procedure
during the implantation procedure hospitalization
Rate and reason for conversion
during the implantation procedure hospitalization
Rate of transmitted data by Home Monitoring
through study completion, an average of 6 months
- +7 more secondary outcomes
Other Outcomes (1)
Medico-economic evaluation
through study completion, an average of 6 months
Study Arms (2)
Sites selected for the same-day organisation
Patients will be admitted to the hospital and leave it on the same-day of the procedure.
Sites with standard overnight hospitalization
Standard organisation with a minimum of one night's stay
Interventions
In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process
Eligibility Criteria
Only patients with an indication for a CRT-P system according to current clinical practice and who are already planned to be implanted with a CRT system according to the investigator's decision may be enrolled in this submodule.
You may qualify if:
- Planned de novo implantation or upgrade to a Cardiac Resynchronization Therapy Pacemaker system according to the intended use
- Patient is able to understand the nature of the registry and has provided written informed consent for BIO\|STREAM.HF (heart failure registry) and the registry-based trial BIO\|OEDIPE.CRT-P
- Patient enrolled in BIO\|STREAM.HF (heart failure registry)
You may not qualify if:
- Patients in emergency situation or without medical assessment before hospitalisation for implantation
- Patients previously implanted with an implantable cardiac defibrillator system
- Patients with an implantable cardiac defibrillator indication
- Patients planned to be implanted with an epicardial left ventricular lead (not implanted via the coronary sinus)
- Patients planned to be implanted with His bundle pacing system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
GCS Centre de Cardiologie du Pays Basque
Bayonne, France
CHU Brest
Brest, France
CHU Caen
Caen, France
Hôpital Louis Pasteur
Chartres, France
Hôpital Saint Philibert
Lomme, France
CH Bretagne Sud
Lorient, France
CHU La Timone
Marseille, France
Hôpital Privé Jacques Cartier
Massy, France
Clinique Les Fontaines
Melun, France
CHU Montpellier
Montpellier, France
Clinique du Millénaire
Montpellier, France
Hôpital Privé du Confluent
Nantes, France
Hôpital La Pitié-Salpêtrière
Paris, France
CHU Saint Etienne
Saint-Etienne, France
CH Saint Lô
Saint-Lô, France
Nouvel Hôpital Civil
Strasbourg, France
Clinique Pasteur
Toulouse, France
CHRU de Tours - Hôpital Trousseau
Tours, France
CH Valence
Valence, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Luc Pasquié, Prof.
University Hospital, Montpellier
- PRINCIPAL INVESTIGATOR
Jacques Mansourati, Prof.
University Hospital, Brest
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
December 2, 2021
Study Start
December 6, 2021
Primary Completion
January 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
December 26, 2025
Record last verified: 2025-12