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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT00878527
Eligibility Criteria:
Inclusion Criteria:
* Maximum tolerable medical therapy including ACE inhibitors and Beta Blockers
* NYHA Class III or IV despite maximal tolerable medical therapy
* Ambulatory (inpatient or outpatient)
* Patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant)
* Life expectancy of at least 6 months without full VAD support
Exclusion Criteria:
* Age \>75 years
* Exercise tolerance limited by factors other than heart failure
* Presence of intra-atrial thrombus
* Clinically significant right heart failure
* Serum creatinine \>/= 2.5 mg/dl or any dialysis in previous 3 months
* Evidence of intrinsic hepatic disease
* Previous episode of resuscitated sudden death without subsequent treatment with AICD
* Subclavian artery stenosis
* Low platelet count, INR that cannot be corrected prior to implant or contraindication to anticoagulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00878527
Study Brief:
Protocol Section:
NCT00878527