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

Biotronik SE & Co. KG354 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

354

Conditions

Heart Failure

Interventions

Ambulatory procedureOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

GCS Centre de Cardiologie du Pays Basque

Bayonne, France

CHU Brest

Brest, France

CHU Caen

Caen, France

Outcomes

Primary Outcomes

Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation.

Number of Serious Adverse Events

Time frame: over the 6-month follow-up duration

Secondary Outcomes

Duration of hospitalisation

Duration of hospitalisation in days

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: during the implantation procedure hospitalization

Rate of transmitted data by Home Monitoring

Data from ClinicalTrials.gov

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