One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
- Conditions
- Heart Failure
- Interventions
- Other: Ambulatory procedure
- Registration Number
- NCT05142293
- Lead Sponsor
- Biotronik SE & Co. KG
- Brief Summary
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 436
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sites selected for the same-day organisation Ambulatory procedure Patients will be admitted to the hospital and leave it on the same-day of the procedure.
- Primary Outcome Measures
Name Time Method Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation. over the 6-month follow-up duration Number of Serious Adverse Events
- Secondary Outcome Measures
Name Time Method Duration of hospitalisation 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
Evaluation of quality of life 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).
Occurence of atrial and ventricular arrhythmias as detected by Home Monitoring through study completion, an average of 6 months Number of atrial and ventricular arrhythmias as detected by Home Monitoring
Number of persons in charge of analyzing the Home Monitoring data through study completion, an average of 6 months Number of persons in charge of analyzing the Home Monitoring data in each site
Rate and reason for not selecting patient for a same-day procedure 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
Rate of transmitted data by Home Monitoring through study completion, an average of 6 months Number and percentage of data that were transmitted through the Home Monitoring technology
Rate and reason for conversion 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
Description of the basic programming of the pacemaker through study completion, an average of 6 months Description of the mode that has been chosen by the physician to program the pacemaker
All serious adverse events including patient deaths; all adverse device effects; all cardiovascular adverse events; all device deficiencies through study completion, an average of 6 months Number of each
Chronotropic incompetence and influence of closed loop stimulation on the cardiac resynchronization therapy efficacy through study completion, an average of 6 months Description of the programmation of the chronotropic incompetence
Rate of patients that performed stress tests through study completion, an average of 6 months Number and percentage of patients that performed stress tests
Patient self-assessment 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
Trial Locations
- Locations (22)
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
CH Saint Lô
🇫🇷Saint-Lô, France
CHU Saint Etienne
🇫🇷Saint-Étienne, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
CHU Toulouse
🇫🇷Toulouse, France
Clinique Pasteur
🇫🇷Toulouse, France
CHRU de Tours - Hôpital Trousseau
🇫🇷Tours, France
CH Valence
🇫🇷Valence, France