One Day Implantation Program for Heart Failure Patients Implanted With CRT-P (OEDIPE-CRT-P)

September 1, 2026 updated by: Biotronik SE & Co. KG

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bayonne, France
        • GCS Centre de Cardiologie du Pays Basque
      • Brest, France
        • CHU Brest
      • Caen, France
        • CHU Caen
      • Chartres, France
        • Hôpital Louis Pasteur
      • Lomme, France
        • Hôpital Saint Philibert
      • Lorient, France
        • CH Bretagne Sud
      • Marseille, France
        • CHU La Timone
      • Massy, France
        • Hôpital Privé Jacques Cartier
      • Melun, France
        • Clinique Les Fontaines
      • Montpellier, France
        • CHU Montpellier
      • Montpellier, France
        • Clinique du Millénaire
      • Nantes, France
        • Hopital prive du Confluent
      • Paris, France
        • Hôpital La Pitié-Salpêtrière
      • Saint-Etienne, France
        • CHU Saint Etienne
      • Saint-Lô, France
        • CH Saint Lô
      • Strasbourg, France
        • Nouvel hopital civil
      • Toulouse, France
        • Clinique Pasteur
      • Tours, France
        • CHRU de Tours - Hôpital Trousseau
      • Valence, France
        • CH Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sites selected for the same-day organisation
Patients will be admitted to the hospital and leave it on the same-day of the procedure.
Other: Ambulatory procedure
In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process
Sites with standard overnight hospitalization
Standard organisation with a minimum of one night's stay

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
over the 6-month follow-up duration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Duration of hospitalisation in days
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
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).
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
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
during the implantation procedure hospitalization
Rate and reason for conversion
Time Frame: during the implantation procedure hospitalization
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
during the implantation procedure hospitalization
Rate of transmitted data by Home Monitoring
Time Frame: through study completion, an average of 6 months
Number and percentage of data that were transmitted through the Home Monitoring technology
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 atrial and ventricular arrhythmias as detected by Home Monitoring
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
Number of persons in charge of analyzing the Home Monitoring data in each site
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
Description of the mode that has been chosen by the physician to program the pacemaker
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
Number of each
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
Description of the programmation of the chronotropic incompetence
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
Number and percentage of patients that performed stress tests
through study completion, an average of 6 months
Patient self-assessment
Time Frame: through study completion, an average of 6 months
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
through study completion, an average of 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medico-economic evaluation
Time Frame: through study completion, an average of 6 months
Cost-utility analysis to compare the efficiency of the same-day and overnight approaches.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Luc Pasquié, Prof., University Hospital, Montpellier
  • Principal Investigator: Jacques Mansourati, Prof., University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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