Heart FailureOEDIPE-CRT-PNCT05142293
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 19 sites in France.
Trial summary
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ambulatory procedure
- How many people
- 354 participants
- Where
- 19 sitesFrance
- Study dates
- 6 Dec 2021to 24 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
GCS Centre de Cardiologie du Pays Basque
Bayonne
CHU Brest
Brest
CHU Caen
Caen
Hôpital Louis Pasteur
Chartres
Hôpital Saint Philibert
Lomme
CH Bretagne Sud
Lorient
CHU La Timone
Marseille
Hôpital Privé Jacques Cartier
Massy
Clinique Les Fontaines
Melun
CHU Montpellier
Montpellier
Clinique du Millénaire
Montpellier
Hôpital Privé du Confluent
Nantes
Hôpital La Pitié-Salpêtrière
Paris
CHU Saint Etienne
Saint-Etienne
CH Saint Lô
Saint-Lô
Nouvel Hôpital Civil
Strasbourg
Clinique Pasteur
Toulouse
CHRU de Tours - Hôpital Trousseau
Tours
CH Valence
Valence
About this study
Official title: One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
Read the detailed description
The objective of the study is to show in the French centers selected for the same-day organization that a same-day CRT-P implantation is safe, feasible, and associated with significant cost-saving and a minimum conversion rate to full hospitalization by comparing outcomes with patients routinely hospitalized for at least one night. The medical economic evaluation will be based on the SNDS (National Health Data System) analysis.
- Conditions
- Heart Failure
- Being tested
- Ambulatory procedure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory procedureOther
In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process
| Study group | Role | What they receive |
|---|---|---|
| Sites selected for the same-day organisation | Patients will be admitted to the hospital and leave it on the same-day of the procedure. Receives: Other: Ambulatory procedure | |
| Sites with standard overnight hospitalization | Standard organisation with a minimum of one night's stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation.
Number of Serious Adverse Events
Measured: over the 6-month follow-up duration
Secondary outcomes (12)
Duration of hospitalisation
Duration of hospitalisation in days
Measured: 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
The patient current health state will be estimated from the answers given by EuroQoL 5D (EQ-5D-5L) questionnaire. The EQ-5D-5L is a self-administered two-part instrument. The first part consists of 5 questions to assess current health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The second part is a 20 centimeters visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: At baseline and 6 months of follow-up
Rate and reason for not selecting patient for a same-day procedure
Number and percentage of patients that were not selected for same-day procedure and the reason why they were not selected for same-day procedure through a questionnaire
Measured: during the implantation procedure hospitalization
Rate and reason for conversion
Number and percentage of patients that were initially elective to same-day procedure but who finally were hospitalized for at least one night and the reason why they were converted to full hospitalization through a questionnaire
Measured: during the implantation procedure hospitalization
Rate of transmitted data by Home Monitoring
Number and percentage of data that were transmitted through the Home Monitoring technology
Measured: through study completion, an average of 6 months
Occurence of atrial and ventricular arrhythmias as detected by Home Monitoring
Number of atrial and ventricular arrhythmias as detected by Home Monitoring
Measured: through study completion, an average of 6 months
Number of persons in charge of analyzing the Home Monitoring data
Number of persons in charge of analyzing the Home Monitoring data in each site
Measured: through study completion, an average of 6 months
Description of the basic programming of the pacemaker
Description of the mode that has been chosen by the physician to program the pacemaker
Measured: through study completion, an average of 6 months
All serious adverse events including patient deaths; all adverse device effects; all cardiovascular adverse events; all device deficiencies
Number of each
Measured: through study completion, an average of 6 months
Chronotropic incompetence and influence of closed loop stimulation on the cardiac resynchronization therapy efficacy
Description of the programmation of the chronotropic incompetence
Measured: through study completion, an average of 6 months
Rate of patients that performed stress tests
Number and percentage of patients that performed stress tests
Measured: through study completion, an average of 6 months
Patient self-assessment
Description of the patient self-assessment during follow-ups through a questionnaire : Markedly improved Moderately improved Slightly improved Remained unchanged Slightly worsened Moderately worsened Markedly worsened
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start6 Dec 2021
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Pasquié, Prof., Principal investigator, University Hospital, MontpellierJacques Mansourati, Prof., Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142293
- Sponsor's protocol ID
- CR027
- Acronym
- OEDIPE-CRT-P
- Status last verified
- Dec 2025
- First submitted
- 25 Oct 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers
- ClinicalTrials.gov ID
- NCT05142293
- Acronym / sponsor ID
- OEDIPE-CRT-P / CR027
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
Detailed description
The objective of the study is to show in the French centers selected for the same-day organization that a same-day CRT-P implantation is safe, feasible, and associated with significant cost-saving and a minimum conversion rate to full hospitalization by comparing outcomes with patients routinely hospitalized for at least one night. The medical economic evaluation will be based on the SNDS (National Health Data System) analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sites selected for the same-day organisation | – | Other: Ambulatory procedurePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory procedureIn the same-day hospitalization group, some patients will be hospitalized on an ambulatory process | Other | Sites selected for the same-day organisation |
Primary outcome
Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation.
Time frame: over the 6-month follow-up duration
Number of Serious Adverse Events
12 secondary outcomes
Duration of hospitalisation
Time frame: 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
Time frame: At baseline and 6 months of follow-up
Rate and reason for not selecting patient for a same-day procedure
Time frame: during the implantation procedure hospitalization
Rate and reason for conversion
Time frame: during the implantation procedure hospitalization
Rate of transmitted data by Home Monitoring
Time frame: through study completion, an average of 6 months
Occurence of atrial and ventricular arrhythmias as detected by Home Monitoring
Time frame: through study completion, an average of 6 months
Number of persons in charge of analyzing the Home Monitoring data
Time frame: through study completion, an average of 6 months
Description of the basic programming of the pacemaker
Time frame: through study completion, an average of 6 months
All serious adverse events including patient deaths; all adverse device effects; all cardiovascular adverse events; all device deficiencies
Time frame: through study completion, an average of 6 months
Chronotropic incompetence and influence of closed loop stimulation on the cardiac resynchronization therapy efficacy
Time frame: through study completion, an average of 6 months
Rate of patients that performed stress tests
Time frame: through study completion, an average of 6 months
Patient self-assessment
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Pasquié, Prof. principal investigator
University Hospital, Montpellier
Jacques Mansourati, Prof. principal investigator
University Hospital, Brest
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation. (time frame: over the 6-month follow-up duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.