FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Completed · Not applicable
Conditions studied: Cardiac Arrhythmias, Heart Failure
In brief
The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).
Key facts
- Study ID
- NCT00418314
- Run by
- Abbott Medical Devices
- People needed
- 1647
- Starts
- 2006-10-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2019-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM) CRT¬D device with VV timing and a compatible lead system.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- Patient has the ability to independently comprehend and complete a QOL questionnaire.
You may not qualify if…
- Patient has an epicardial ventricular lead system.
- Patient has the ability to walk ≥ 450 meters in 6 minutes
- Patient has limited intrinsic atrial activity (≤ 40 bpm).
- Patient has persistent or permanent atrial fibrillation (AF).
- Patient has a 2° or 3° heart block.
- Patient's life expectancy is less than 1 year.
- Patient is pregnant.
- Patient is on IV inotropic agents.
Where it is running
- Cedars Sinai Hospital — Los Angeles, California, United States
- Ohio State Univeristy — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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