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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00680927
Eligibility Criteria:
Inclusion Criteria:
* Patient is willing and able to provide his/her informed consent
* Patient has been implanted with a Reveal® XT
* Patient fulfills at least one of the following three additional requirements
1. is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or
2. has documented frequent AF or frequent symptoms attributable to AF or
3. has undergone PV ablation within the last 6 months and still has symptoms attributable to AF
Exclusion Criteria:
* Patient has an implanted pacemaker or ICD
* Patient has persistent or permanent AF
* Patient is allergic to adhesive ECG electrodes
* The study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period
* Patient is participating in another study that is expected to compromise the results of this study
* Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study
* Patient is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00680927
Study Brief:
Protocol Section:
NCT00680927