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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT01786993
Eligibility Criteria:
Inclusion Criteria:
* Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
* Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
* Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
* Have an existing Class I recalled lead
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
* Have permanent atrial fibrillation (AF)
* Have undergone a cardiac transplantation within 40 days of enrollment
* Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 9 months due to any condition
* Are less than 18 years of age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01786993
Study Brief:
Protocol Section:
NCT01786993