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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT00528320
Eligibility Criteria:
Inclusion Criteria:
* Accepted indication for ICD implant
* Severe heart failure (NYHA Class III or IV) at the time of enrollment
* May have pre-existing ICD, provided subject is on stable, optimal medical regime
* Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms
* Left-ventricular ejection fraction (LVEF) of 35% or less
Exclusion Criteria:
* Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing
* Any contraindication for ICD therapy
* Currently implanted with a lead positioned in or through the coronary sinus
* Hypertrophic or obstructive cardiomyopathy
* Acute myocarditis
* Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
* Recent or planned cardiac revascularization or coronary angioplasty
* Correctable valvular disease that is the primary cause of heart failure
* Mechanical tricuspid valve
* Chronic atrial arrhythmia or cardioversion for atrial fibrillation within the past month, or paroxysmal atrial fibrillation requiring new pharmacologic therapy within the past month
* Systolic blood pressure consistently above 170 mmHg or consistently below 80 mmHg
* Supine resting heart rate exceeding 100 bpm
* Receiving continuous IV infusion of positive inotropic therapy or intermittent therapy (IV infusion) more than twice per week
* Heart transplant recipient
* Primary pulmonary disease of a severity that might limit the patient's ability to perform a treadmill test
* Serum creatinine above 3.0 mg/dL
* Serum hepatic functions at or above three times the upper normal limit
* Cerebrovascular event within the previous three months
* Inability to walk or other physical impediments which might prevent the patient from completing a maximum, symptom-limited treadmill test
* Age of less than 18 years
* Pregnancy
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00528320
Study Brief:
Protocol Section:
NCT00528320