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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT05657912
Eligibility Criteria:
Inclusion Criteria:
* Must meet be ≥ 18 years of age.
* Must meet indications for TAVR using approved devices
* Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
* Willing to comply with specified follow-up evaluations.
* Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.
Exclusion Criteria:
* Any implanted device or an indication for treatment with a rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT), or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
* Any contraindication to the TAVR procedure according to the instructions for use.
* Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
* Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05657912
Study Brief:
Protocol Section:
NCT05657912