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

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: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Ambulatory procedure

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

Study Locations

• France
  • Bayonne, France
    • GCS Centre de Cardiologie du Pays Basque
  • Brest, France
    • CHU Brest
  • Caen, France
    • CHU CAEN
  • Chartres, France
    • Hopital Louis Pasteur
  • Lomme, France
    • Hôpital Saint Philibert
  • Lorient, France
    • CH Bretagne Sud
  • Marseille, France
    • CHU La Timone
  • Massy, France
    • Hopital Prive 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 Hôpital Civil
  • Toulouse, France
    • Clinique Pasteur
  • Tours, France
    • CHRU de Tours - Hopital Trousseau
  • Valence, France
    • CH VALENCE

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

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.	Number of Serious Adverse Events	over the 6-month follow-up duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalisation	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	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	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	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	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	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	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	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	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	Description of the programmation of the chronotropic incompetence	through study completion, an average of 6 months
Rate of patients that performed stress tests	Number and percentage of patients that performed stress tests	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	through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medico-economic evaluation	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

• 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

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): May 31, 2026

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): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Surgical Procedures, Operative; Ambulatory Surgical Procedures
• 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