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

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

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Ambulatory procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sites selected for the same-day organisation<br>Patients will be admitted to the hospital and leave it on the same-day of the procedure. | Other: Ambulatory procedure<br>* In the same-day hospitalization group, some patients will be hospitalized on an ambulatory process<br>|
| Sites with standard overnight hospitalization<br>Standard organisation with a minimum of one night's stay | |

What is the study measuring?
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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 |