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NCT Number: NCT05142293

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

This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GCS Centre de Cardiologie du Pays Basque, Bayonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory procedure

Other

In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers

Acronym: OEDIPE-CRT-P

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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