Status:
COMPLETED
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Arrhythmias
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 d...
Detailed Description
* This is a prospective, double-blinded, multicenter, randomized study * Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1647 Patients enrolled
Trial Details
Trial ID
NCT00418314
Start Date
October 1 2006
End Date
September 1 2009
Last Update
February 19 2019
Active Locations (2)
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1
Cedars Sinai Hospital
Los Angeles, California, United States, 90048
2
Ohio State Univeristy
Columbus, Ohio, United States, 43210