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

Biotronik

Status

Active, not recruiting

Conditions

Heart Failure

Treatments

Other: Ambulatory procedure

Study type

Observational

Funder types

Industry

Identifiers

NCT05142293

CR027

Details and patient eligibility

About

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

Full 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.

Enrollment

354 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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