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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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 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

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
Intervention / Treatment
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

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

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

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

Biotronik SE & Co. KG

Investigators

  • 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)

December 6, 2021

Primary Completion (Actual)

July 24, 2025

Study Completion (Actual)

July 24, 2025

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 20, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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