- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418314
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
February 1, 2019 updated by: Abbott Medical Devices
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 3, 6, 9 and 12 months
- Patients will be randomized at enrollment to either Group 1 ("QuickOpt Group") or Group 2 ("Control Group").
- Group 1 - The patient's device is programmed to sequential biventricular pacing mode with AV/PV and VV delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits.
- Group 2 - The patient's device is programmed to either simultaneous or sequential BiV pacing mode as per physician's discretion. The AV/PV and inter-ventricular (VV) delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post implant. Any AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations.
Study Type
Interventional
Enrollment (Actual)
1647
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Hospital
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QuickOpt (Treatment)
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Frequent optimization using QuickOpt to optimize AV/PV and VV delays.
|
Active Comparator: Control
Empiric programming or one-time optimization using a non-IEGM method.
|
Empiric programming or one-time optimization using a non-IEGM method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Failure Clinical Composite Score
Time Frame: 12 months
|
The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial.
Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial.
Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit.
Patients are considered unchanged if they are neither improved nor worse.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause, Cardiovascular and Heart Failure Mortality;
Time Frame: 12 months
|
12 months
|
All Cause, Cardiovascular and Heart Failure Hospitalization
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Abraham, MD, Ohio State University, Columbus, OH, USA
- Principal Investigator: Daniel Gras, MD, Nouvelles Cliniques Nantaises, Nantes, France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
January 3, 2007
First Submitted That Met QC Criteria
January 3, 2007
First Posted (Estimate)
January 4, 2007
Study Record Updates
Last Update Posted (Actual)
February 19, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRD378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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