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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00626093
Eligibility Criteria:
Inclusion Criteria:
* Patient meets standard indications for a Cardiac Resynchronization Therapy - Defibrillator (CRT-D).
* Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead system.
* Patient is able to tolerate defibrillation threshold (DFT) testing.
* Patient is geographically stable and willing to comply with the required follow-up schedule.
* Patient has a life expectancy of greater than 6 months from the time of implant.
* Patient has stable heart failure (HF) medications at least one month prior to enrollment.
Exclusion Criteria:
* Inability to successfully implant an intravascular lead Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).
* Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device replaced.
* Inability to successfully obtain the defibrillation threshold (DFT) at implant.
* Currently participating in a clinical trial that includes an active treatment arm or another data collection registry.
* Recent (within 24 hours) administration of Nesiritide™.
* Patient is on amiodarone (other antiarrhythmic agents known to affect defibrillation thresholds - DFTs) at the time of enrollment.
* Patient is pregnant.
* Patient is less than 18 years old.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00626093
Study Brief:
Protocol Section:
NCT00626093