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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00547794
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic permanent AF
* Class I or II indication for ICD
* LVEF ≤ 35% within 6 months
* NYHA class II or III with a history of CHF
* Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days
* Ability to independently comprehend and complete a QoL questionnaire
* Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations
Exclusion Criteria:
* Paroxysmal or persistent AF
* Class I indication for pacing (including AVJ ablation for poor rate control)
* Ability to walk ≥ 450 meters in 6 minutes
* Musculoskeletal disorders that prohibit the completion of a 450 meters walk
* NYHA class I or IV at the time of enrollment
* A contraindication to taking Coumadin therapy
* History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days
* History of mitral valve surgery
* Prior attempts for cardiac resynchronization therapy
* The presence of an existing coronary sinus lead or epicardial lead
* Life expectancy \< 1year
* Age \< 18 yrs
* Current participation in other clinical studies except registry trials
* Use of calcium channel blockers
* Pregnancy
* Inability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00547794
Study Brief:
Protocol Section:
NCT00547794