Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT05142293
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05142293
Study Brief:
Protocol Section:
NCT05142293