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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT02914457
Eligibility Criteria:
Inclusion Criteria:
* Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines
* Subject is in sinus rhythm
* Subject receives optimal heart failure oral medical therapy
* Subject is willing to sign the informed consent form
* Subject is 18 years or older
Exclusion Criteria:
* Subject has permanent atrial fibrillation/flutter or tachycardia
* Subject has pure right bundle branch block (= no additional left ventricular conduction delays)
* Subject has left bundle branch block and QRS-duration of \> 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI
* Subject experienced recent myocardial infarction, within 40 days prior to enrollment
* Subject underwent valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation, or is actively listed on the transplantation list
* Subject is implanted with a left ventricular assist device
* Subject has severe renal disease (up to physicians discretion)
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period)
* Subject has complex and uncorrected congenital heart disease
* Subject has a mechanical heart valve
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
* Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02914457
Study Brief:
Protocol Section:
NCT02914457