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

Heart Failure Clinical Trial

— OEDIPE-CRT-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142293
• Other study ID #: CR027
• Status: Recruiting
• Start date: December 6, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: September 2023
• Source: Biotronik SE & Co. KG
• Contact: Amandine Wouters
• Phone: +33(0)146759660
• Email: bio-oedipe[@]biotronik.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 436
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Ambulatory procedure
In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process

Locations

Country	Name	City	State
France	GCS Centre de Cardiologie du Pays Basque	Bayonne
France	CHU Brest	Brest
France	CHU Caen	Caen
France	Hôpital Louis Pasteur	Chartres
France	CHU Dupuytren	Limoges
France	Hôpital Saint Philibert	Lomme
France	CH Bretagne Sud	Lorient
France	CHU La Timone	Marseille
France	Hôpital Privé Jacques Cartier	Massy
France	Clinique Les Fontaines	Melun
France	CHU Montpellier	Montpellier
France	Clinique du Millénaire	Montpellier
France	Hôpital Privé du Confluent	Nantes
France	Hôpital La Pitié-Salpêtrière	Paris
France	CHU Haut Lévèque	Pessac
France	CHU Saint Etienne	Saint-Étienne
France	CH Saint Lô	Saint-Lô
France	Nouvel Hôpital Civil	Strasbourg
France	CHU Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	CHRU de Tours - Hôpital Trousseau	Tours
France	CH Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of patients that performed stress tests	Number and percentage of patients that performed stress tests	through study completion, an average of 6 months
Secondary	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