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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00521534
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18years
* Indication for CRT device implant:
* Congestive heart failure (NYHA Class III or IV)
* Ejection fraction less than 36%
* Evidence of intraventricular dyssynchrony (QRS duration \>120ms or positive tissue doppler echocardiogram).
* Have a life expectancy of at least 6 months
* Are on optimal pharmaceutical therapy (OPT)
* Ability and willingness to sign informed consent
Exclusion Criteria:
* Unstable angina, Canadian Cardiac Society Class III or greater.
* Patients with unstable heart failure defined as need for intravenous inotropes or inability to achieve stable medical regimen for 48 hours.
* Deterioration in CHF at any time during the study requiring hospital admission and any of the following:
* A significant change in pharmaceutical regimen (see below: Pharmacologic Therapy)
* A change in pacing mode parameters (with the exception of if the mode is inadvertently programmed incorrectly at implant)
* A need for inotrope support
* A downward change in functional class by one grade at discharge
* Women of childbearing age who are pregnant or who refuse pregnancy test and reliable contraception means for the duration of the study.
* Not having a successful percutaneous CRT device implant.
* Chronic atrial fibrillation.
* Patients currently known to have sleep apnea for which they are being treated with CPAP. (Patients prescribed to CPAP who have not been compliant for one month or greater are eligible for enrollment.)
* AHI \>50 on any PSG or portable sleep study.
* Mean nocturnal heart rate \> 80 bpm on baseline PSG will exclude from randomization.
* Patients receiving, narcotics or benzodiazepines unless on stable doses.
* Current alcohol or narcotic abuse as documented in the patient medical record.
* Inability or unwillingness to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00521534
Study Brief:
Protocol Section:
NCT00521534