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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00418314 |
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Date of registration:
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03/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
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Scientific title:
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FREEDOM - A Frequent Optimization Study Using the QuickOpt Method |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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1647 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00418314 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel Gras, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nouvelles Cliniques Nantaises, Nantes, France |
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Name:
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William Abraham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University, Columbus, OH, USA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiac Arrhythmias
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Heart Failure
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Intervention(s)
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Device: Control
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Device: QuickOpt
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Primary Outcome(s)
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Heart Failure Clinical Composite Score
[Time Frame: 12 months]
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Secondary Outcome(s)
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All-cause, Cardiovascular and Heart Failure Mortality;
[Time Frame: 12 months]
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All Cause, Cardiovascular and Heart Failure Hospitalization
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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