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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07103733
Eligibility Criteria:
Inclusion Criteria:
* Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.
* For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.
Exclusion Criteria:
* Severe claustrophobia not controlled with sedation.
* Prior adverse reaction to gadolinium administration.
* Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.
* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07103733
Study Brief:
Protocol Section:
NCT07103733