Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
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|ClinicalTrials.gov Identifier: NCT00112125|
Recruitment Status : Completed
First Posted : May 30, 2005
Results First Posted : August 6, 2020
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Device: OPTIMIZER System||Not Applicable|
IMPULSE Dynamics' FIX HF 5 US Study is a prospective, multi-center, study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER™ System in patients with NYHA class III/IV heart failure. The study will involve the recruitment of approximately 420 subjects at a total of up to 50 sites nationwide.
Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomized to receive the OPTIMIZER™ System or to a control group. All subjects randomized will be followed for 1 year and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive optimal medical therapy for the treatment of their heart failure.
The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months. Safety variables, such as the rate and cause of hospitalizations or death, shall be collected in both groups and shall be compared at 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety and Efficacy of the OPTIMIZER System With Active Fixation Leads in Subjects With Heart Failure Resulting From Systolic Dysfunction: FIX-HF-5|
|Actual Study Start Date :||February 2005|
|Actual Primary Completion Date :||March 19, 2019|
|Actual Study Completion Date :||March 19, 2019|
Experimental: Optimizer System + Optimal medical treatment
Optimizer System implanted and cardiac contractility modulation therapy activated.
Device: OPTIMIZER System
No Intervention: Optimal medical treatment
Treatment with optimal medical therapy only.
- Efficacy Endpoint: Ventilatory Anerobic Threshold (VAT) [ Time Frame: 24 weeks ]
Number of participants with improvement in exercise tolerance at 24 weeks compared to baseline, as quantified by VO2 at ventilatory anerobic threshold (VAT) measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab.
Note: An individual subject is considered a responder if VAT increases by ≥20% at 24 weeks compared to their respective baseline value.
- Safety Endpoint: Composite All-cause Mortality and All-cause Hospitalizations [ Time Frame: 50-weeks ]The proportion of patients experiencing a composite event of all-cause mortality and all-cause hospitalizations evaluated at 50-weeks
- Peak VO2 [ Time Frame: 24 weeks ]
Number of participants with improvement in peak VO2 measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab.
Note: An individual subject is considered a responder if peak VO2 increases by ≥20% at 24 weeks compared to their respective baseline value.
- New York Heart Association (NYHA) Functional Classification [ Time Frame: 24 weeks ]
Number of participants with improvement in heart failure symptoms as quantified by a blinded clinician using the New York Heart Association (NYHA) functional classification at 24 weeks compared to baseline. The NYHA Class ranges from I - IV, with a lower class indicating a better status.
Note: An individual subject is considered a responder if the NYHA class decreases by ≥ 1 at 24 weeks compared to their respective baseline class.
- Minnesota Living With Heart Failure (MLWHF) Questionnaire [ Time Frame: 24 weeks ]
Number of subjects will improvement in quality of life at 24 weeks compared to baseline, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The MLWHFQ score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Note: An individual subject is considered a responder if the MLWHFQ score decreases by ≥10 points at 24 weeks compared to their respective baseline score.
- Six Minute Hall Walk (6MW) Test [ Time Frame: 24 weeks ]
Number of subjects with improvement in exercise tolerance at 24 weeks compared to baseline, as assessed by the the six minute hall walk (6MW) test.
Note: An individual subject is considered a responder with >40-meter increase in distance walked at 24 weeks compared to their respective baseline distance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112125
|United States, New York|
|Orangeburg, New York, United States, 10962|
|Study Director:||Dan Burkhoff, M.D, Ph.D.||Impulse Dynamics|