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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01519908
Eligibility Criteria:
Inclusion Criteria:
* Subject is indicated for CRT-D device according to current applicable ESC/AHA guidelines
* Subject has NYHA class II or III
* Subject has stable sinus rhythm (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion) No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
* Intrinsic QRS-width ≥ 130 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class II
* Intrinsic QRS-width ≥ 120 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class III
* Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
* Subject is willing to sign informed consent form
* Subject is 18 years or older
Exclusion Criteria:
* Subject is upgraded from a bradycardia pacemaker to CRT-D
* Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
* Subject has permanent atrial fibrillation/ flutter or tachycardia.
* Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
* Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
* Subject is implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
* Subject is on chronic renal dialysis
* Subject has severe renal disease (defined as Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2)
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
* Subject has RBBB
* Subject has permanent 2nd or 3rd degree AV-block
* 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 right heart valve
* Subject has a life expectancy of less than one year in the opinion of the investigator
* 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 one or more concurrent studies that would confound the results of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01519908
Study Brief:
Protocol Section:
NCT01519908