Active — Not RecruitingNot Applicable

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

France354 participantsStarted 2021-12-06

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT05142293

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Heart Failure trials