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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT01097733
Eligibility Criteria:
Inclusion Criteria:
* Older than 18 years of age
* Ability to provide informed consent
* Planned CRT implantation
* NYHA Functional Class II-IV heart failure
* Echo Ejection Fraction less than or equal to 35%
* QRS duration greater than or equal to 120 ms
* Normal or mildly reduced kidney function (estimated serum creatinine less than or equal to 1.5 mg/dL or less than or equal to 1.3 mg/dL for diabetic subjects on metformin
* For diabetic subjects on glucophage (metformin) they will be required to stop glucophage (metformin) for at least 48 hours after the administration of contrast.
Exclusion Criteria:
* Known allergy to iodine or iodinated contrast
* Chronic persistent atrial fibrillation
* Pregnancy or unknown pregnancy status
* Subjects on glucophage (metformin) therapy that are unable or unwilling to discontinue therapy for 48 hours after CT scan
* Known inadequate venous access for appropriate IV caliber placement
* Iodinated contrast administration within the past 48 hours
* Subjects who cannot hold their breath for 10-15 seconds
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01097733
Study Brief:
Protocol Section:
NCT01097733