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:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT06748157
Eligibility Criteria:
Inclusion Criteria
* Men and women ages ≥18 years
* Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure.
* Ability and willingness to sign an informed consent form.
* Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone.
Exclusion Criteria
* Rheumatic heart disease
* Extensive atrial disease (\* some patients may be determined to be screen failures following the ablation procedure).
* Moderate to severe mitral stenosis or history of mitral valve replacement
* Pacemaker or CRTD or any implanted electrical stimulating device
* Unilateral or bilateral vagotomy
* Peripheral neuropathy affecting the tested upper extremity.
* Severe heart failure (New York Heart Association Class III or IV) within 90 days.
* Recent (within 90 days) stroke or transient ischemic attack.
* Recent (within 90 days) myocardial infarction.
* Pregnancy or breast feeding.
* Life expectancy \<1 year for any medical condition
* Currently enrolled in another study that would interfere with this study
* Unsuitable for participating in the study according to attending physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06748157
Study Brief:
Protocol Section:
NCT06748157