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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT04629066
Eligibility Criteria:
Inclusion Criteria:
* Patients have a MERLIN patient registry record for an ICD or CRT-D implantation between 01/01/2010-12/31/2020
* Age \> 18 years
* Left ventricular ejection fraction \< 50% by echocardiogram, nuclear cardiology scan, cardiac magnetic resonance imaging, or invasive left ventriculography within the past 12 months.
* Ongoing NYHA class II, III, or IV HF symptoms by questionnaire
* Ongoing use of beta-blocker and ACE-inhibitor or angiotensin receptor blocker or willingness to start them- assessed by Duke Epic EMR screening.
* Life expectancy \> 12 months
* To allow for a post-surgical adjustment period, patients must be \>30 days out from device implantation
Exclusion Criteria:
* Prior participation in CR- by patient questionnaire
* Unwillingness to sign informed consent form
* Currently performing \> 240 minutes of device detected daily PA- by ICD/CRTD remotely collected data.
* Lack of a smartphone or unwillingness to use an App or Fitbit device
* Prior left ventricular assist device (LVAD) implantation or heart transplantation
* ICD tachyarrhythmia therapies programmed off
* Inherited arrhythmia condition with contraindication to exercise (eg Lamin A mutation or ARVC)
* No transmissions through Merlin.net in past 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04629066
Study Brief:
Protocol Section:
NCT04629066