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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05019833
Eligibility Criteria:
Inclusion Criteria:
* Patient with class I or II indication for implantation of a CRT-D device according to current ESC guidelines
* Patient newly implanted with a MicroPort CRM Platinium CRT-D SonR or Platinium CRT-D device within 2 months before the Investigational Procedure
* Patient in sinus rhythm with a preserved atrio-ventricular conduction, and PR interval=220 +/- 30 ms on surface ECG
* Patient has reviewed, signed and dated the study informed consent form
Exclusion Criteria:
* Patient with permanent or persistent atrial fibrillation or atrial flutter
* Patient presenting with a permanent or frequent paroxysmal high degree atrio-ventricular block
* Device upgrade or replacement
* Minor patient (i.e. under 18 years of age), or patient under guardianship or kept in detention
* Patient unavailable for the scheduled Investigational Procedure, not able to understand the purpose of this study or refusing to cooperate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05019833
Study Brief:
Protocol Section:
NCT05019833