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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT07093034
Eligibility Criteria:
Inclusion Criteria
Individuals must meet all of the following inclusion criteria to be eligible to participate in this study:
Age ≥ 18 years
PVC burden ≥ 5% documented on an event monitor or implanted cardiac device
Provide written informed consent
Willingness to comply with all study procedures
Availability for the duration of the study (10 weeks)
Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation:
Unwilling or unable to provide informed consent for oneself
Last available left ventricular ejection fraction \< 20%
NYHA Class IV symptoms
Acute coronary syndrome within two weeks of randomization
Active pregnancy or breastfeeding
Intention to become pregnant
Statement Regarding Equitable Selection:
This study will not exclude specific populations based on age, sex, race, or ethnicity. The inclusion/exclusion criteria are based on clinical factors relevant to the study intervention and the safety of participants. Limited English proficiency will not be an exclusion criterion, and appropriate translation services will be provided to ensure informed consent and understanding of study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07093034
Study Brief:
Protocol Section:
NCT07093034