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

Last updated: October 10, 2024
Sponsor: Biotronik SE & Co. KG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

Ambulatory procedure

Clinical Study ID

NCT05142293
CR027
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Planned de novo implantation or upgrade to a Cardiac Resynchronization TherapyPacemaker system according to the intended use

  • Patient is able to understand the nature of the registry and has provided writteninformed consent for BIO|STREAM.HF (heart failure registry) and the registry-basedtrial BIO|OEDIPE.CRT-P

  • Patient enrolled in BIO|STREAM.HF (heart failure registry)

Exclusion

Exclusion Criteria:

  • Patients in emergency situation or without medical assessment before hospitalisationfor 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 (notimplanted via the coronary sinus)

  • Patients planned to be implanted with His bundle pacing system

Study Design

Total Participants: 436
Treatment Group(s): 1
Primary Treatment: Ambulatory procedure
Phase:
Study Start date:
December 06, 2021
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • GCS Centre de Cardiologie du Pays Basque

    Bayonne,
    France

    Active - Recruiting

  • CHU Brest

    Brest,
    France

    Active - Recruiting

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • Hôpital Louis Pasteur

    Chartres,
    France

    Terminated

  • CHU Dupuytren

    Limoges,
    France

    Site Not Available

  • Hôpital Saint Philibert

    Lomme,
    France

    Terminated

  • CH Bretagne Sud

    Lorient,
    France

    Terminated

  • CHU La Timone

    Marseille,
    France

    Terminated

  • Hôpital Privé Jacques Cartier

    Massy,
    France

    Active - Recruiting

  • Clinique Les Fontaines

    Melun,
    France

    Active - Recruiting

  • CHU Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Clinique du Millénaire

    Montpellier,
    France

    Terminated

  • Hôpital Privé du Confluent

    Nantes,
    France

    Active - Recruiting

  • Hôpital La Pitié-Salpêtrière

    Paris,
    France

    Active - Recruiting

  • CHU Haut Lévèque

    Pessac,
    France

    Site Not Available

  • CH Saint Lô

    Saint-Lô,
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Nouvel Hôpital Civil

    Strasbourg,
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse,
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse,
    France

    Terminated

  • CHRU de Tours - Hôpital Trousseau

    Tours,
    France

    Active - Recruiting

  • CH Valence

    Valence,
    France

    Active - Recruiting

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