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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01832493
Eligibility Criteria:
Inclusion Criteria:
* Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.
* Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)
* Subject (or subject's legally authorized representative) must be willing to give informed consent
* Subjects must be at least 18 years of age
Exclusion Criteria:
* Subject has congenital heart disease
* Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure
* Subject has unstable coronary artery disease
* Subject cannot undergo transvenous catheterization
* Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease
* Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control
* Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus
* Subject is pregnant
* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01832493
Study Brief:
Protocol Section:
NCT01832493