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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01640769
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Ejection fraction ≤ 35 %.
3. LBBB with QRS duration ≥ 120 msec.
4. NYHA class II-IV.
5. On maximum tolerated heart failure medication therapy ≥ 6 weeks.
6. Clinically accepted for CRT device implantation.
Exclusion Criteria:
1. Failure to provide consent.
2. CCS class III-IV angina.
3. Recent Q-wave myocardial infarction or revascularization procedure ( ≤ 3 months).
4. Atrial fibrillation at time of randomization \>6 weeks in duration
5. Standard contra-indications to MRI.
6. Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast).
7. Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/m2.
8. Patient is pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01640769
Study Brief:
Protocol Section:
NCT01640769