Clinical trial NCT05142293: One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
Official title: One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only patients with an indication for a CRT-P system according to current clinical practice and who are already planned to be implanted with a CRT system according to the investigator's decision may be enrolled in this submodule.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Events with possible or probable or sure causal relation to the procedure until 6 months after implantation.
timeFrame: over the 6-month follow-up duration
Secondary outcomes:
measure: Duration of hospitalisation
timeFrame: Time between the patient's entry at the hospital and the patient's hospital discharge, an average of 2 days
measure: Evaluation of quality of life
timeFrame: At baseline and 6 months of follow-up
measure: Rate and reason for not selecting patient for a same-day procedure
timeFrame: during the implantation procedure hospitalization
measure: Rate and reason for conversion
timeFrame: during the implantation procedure hospitalization
measure: Rate of transmitted data by Home Monitoring
timeFrame: through study completion, an average of 6 months
measure: Occurence of atrial and ventricular arrhythmias as detected by Home Monitoring
timeFrame: through study completion, an average of 6 months
measure: Number of persons in charge of analyzing the Home Monitoring data
timeFrame: through study completion, an average of 6 months
measure: Description of the basic programming of the pacemaker
timeFrame: through study completion, an average of 6 months
measure: All serious adverse events including patient deaths; all adverse device effects; all cardiovascular adverse events; all device deficiencies
timeFrame: through study completion, an average of 6 months
measure: Chronotropic incompetence and influence of closed loop stimulation on the cardiac resynchronization therapy efficacy
timeFrame: through study completion, an average of 6 months
measure: Rate of patients that performed stress tests
timeFrame: through study completion, an average of 6 months
measure: Patient self-assessment
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: Medico-economic evaluation
timeFrame: through study completion, an average of 6 months
Locations:
city: Bayonne
country: France
facility: GCS Centre de Cardiologie du Pays Basque
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Chartres
country: France
facility: Hôpital Louis Pasteur
city: Limoges
country: France
facility: CHU Dupuytren
city: Lomme
country: France
facility: Hôpital Saint Philibert
city: Lorient
country: France
facility: CH Bretagne Sud
city: Marseille
country: France
facility: CHU La Timone
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Melun
country: France
facility: Clinique Les Fontaines
city: Montpellier
country: France
facility: CHU Montpellier
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière
city: Pessac
country: France
facility: CHU Haut Lévèque
city: Saint-Lô
country: France
facility: CH Saint Lô
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Toulouse
country: France
facility: CHU Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
city: Valence
country: France
facility: CH Valence
Study officials:
affiliation: University Hospital, Montpellier
name: Jean-Luc Pasquié, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Brest
name: Jacques Mansourati, Prof.
role: PRINCIPAL_INVESTIGATOR
References: