- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112125
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Orangeburg, New York, United States, 10962
- Impulse Dynamics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who are 18 years of age or older
- Subjects who are either male or female
- Subjects who have a baseline ejection fraction of 35% or less by echocardiography.
- Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the patient is intolerant) and are in New York Heart Association functional Class III or IV at the time of enrollment.
- Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.
- Subjects who, in the opinion of the Principle Investigator (based on the current guidelines for clinical practice), have a clinical indication for an implanted cardiac defibrillator (ICD) and/or pacemaker, must have an existing device or agree to undergo implantation of such a device unless the patient refuses to undergo the implantation of such device for personal reasons.
- Subjects who are willing and able to return for all follow-up visits.
Exclusion Criteria:
- Subjects whose baseline VO2,max is <9 ml 02/min/kg.
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or electrocardiography (ECG) changes during exercise testing performed during baseline evaluation.
- Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
- Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular complexes (PVCs) per 24 hours on baseline Holter monitoring.
- Subjects who have chronic atrial fibrillation or chronic atrial flutter or those cardioverted within 30 days of enrollment.
- Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, chronic obstructive pulmonary disease [COPD], peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to participate in a 6-minute walk or a cardiopulmonary stress test.
- Subjects who are scheduled for a coronary artery bypass graft (CABG) or a percutaneous transluminal coronary angioplasty (PTCA) procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
- Subjects who have a biventricular pacing system or who have an accepted indication for such a device.
- Subjects who have had a myocardial infarction within 90 days of enrollment.
- Subjects who have mechanical tricuspid or aortic valves.
- Subjects who have a prior heart transplant.
- Subjects who are participating in another experimental protocol.
- Subjects who are unable to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Optimizer System + Optimal medical treatment
Optimizer System implanted and cardiac contractility modulation therapy activated.
|
|
No Intervention: Optimal medical treatment
Treatment with optimal medical therapy only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
24 weeks
|
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
|
50-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
24 weeks
|
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. |
24 weeks
|
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. |
24 weeks
|
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. |
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dan Burkhoff, M.D, Ph.D., Impulse Dynamics
Publications and helpful links
General Publications
- Burkhoff D, Shemer I, Felzen B, Shimizu J, Mika Y, Dickstein M, Prutchi D, Darvish N, Ben-Haim SA. Electric currents applied during the refractory period can modulate cardiac contractility in vitro and in vivo. Heart Fail Rev. 2001 Jan;6(1):27-34. doi: 10.1023/a:1009851107189. No abstract available.
- Ellison K. Nonexcitatory stimulation: 2002: a pace odyssey. J Cardiovasc Electrophysiol. 2002 Jul;13(7):696-7. doi: 10.1046/j.1540-8167.2002.00696.x. No abstract available.
- Marrouche NF, Pavia SV, Zhuang S, Kim YJ, Tabata T, Wallick D, Saad E, Abdul-Karim A, Schweikert R, Saliba W, Tchou P, Natale A. Nonexcitatory stimulus delivery improves left ventricular function in hearts with left bundle branch block. J Cardiovasc Electrophysiol. 2002 Jul;13(7):691-5. doi: 10.1046/j.1540-8167.2002.00691.x.
- Mohri S, He KL, Dickstein M, Mika Y, Shimizu J, Shemer I, Yi GH, Wang J, Ben-Haim S, Burkhoff D. Cardiac contractility modulation by electric currents applied during the refractory period. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1642-7. doi: 10.1152/ajpheart.00959.2001.
- Morita H, Suzuki G, Haddad W, Mika Y, Tanhehco EJ, Sharov VG, Goldstein S, Ben-Haim S, Sabbah HN. Cardiac contractility modulation with nonexcitatory electric signals improves left ventricular function in dogs with chronic heart failure. J Card Fail. 2003 Feb;9(1):69-75. doi: 10.1054/jcaf.2003.8.
- Mohri S, Shimizu J, Mika Y, Shemer I, Wang J, Ben-Haim S, Burkhoff D. Electric currents applied during refractory period enhance contractility and systolic calcium in the ferret heart. Am J Physiol Heart Circ Physiol. 2003 Apr;284(4):H1119-23. doi: 10.1152/ajpheart.00378.2002. Epub 2002 Nov 21.
- Sabbah HN, Haddad W, Mika Y, Nass O, Aviv R, Sharov VG, Maltsev V, Felzen B, Undrovinas AI, Goldstein S, Darvish N, Ben-Haim SA. Cardiac contractility modulation with the impulse dynamics signal: studies in dogs with chronic heart failure. Heart Fail Rev. 2001 Jan;6(1):45-53. doi: 10.1023/a:1009855208097.
- Pappone C, Rosanio S, Burkhoff D, Mika Y, Vicedomini G, Augello G, Shemer I, Prutchi D, Haddad W, Aviv R, Snir Y, Kronzon I, Alfieri O, Ben-Haim SA. Cardiac contractility modulation by electric currents applied during the refractory period in patients with heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 2002 Dec 15;90(12):1307-13. doi: 10.1016/s0002-9149(02)02868-0.
- Abraham WT, Burkhoff D, Nademanee K, Carson P, Bourge R, Ellenbogen KA, Parides M, Kadish A; FIX-HF-5 Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics. Am Heart J. 2008 Oct;156(4):641-648.e1. doi: 10.1016/j.ahj.2008.05.019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #IDPT 2003-07-C
- FIX-HF-5 (Other Identifier: Impulse Dynamics)
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.
Clinical Trials on Heart Failure, Congestive
-
Echosense Ltd.WithdrawnCongestive Heart Failure (CHF)United States
-
Corthera, Inc.(formerly BAS Medical, Inc.), a member...TerminatedCongestive Heart Failure (CHF)Russian Federation
-
Meir Medical CenterUnknown
-
Nihon KohdenTerminatedHeart Failure,CongestiveUnited States
-
Adnan Kastrati, MDBiotronik SE & Co. KGCompleted
-
Signature Medical, Inc.WithdrawnHeart Failure,Congestive
-
Abbott Medical DevicesCompletedCongestive Heart Failure TreatedItaly
-
Echosense Ltd.Terminated
-
ELA Medical, Inc.Approved for marketing
-
Magenta Medical Ltd.TerminatedCongestive Heart Failure | Heart Failure, Congestive | Acute Heart FailureCroatia, Belgium, Serbia
Clinical Trials on OPTIMIZER System
-
Impulse DynamicsCompletedHeart Failure | Congestive Heart Failure | CHF | Chronic Heart DiseaseUnited States, Germany
-
Impulse DynamicsRecruiting
-
Impulse DynamicsTerminatedHeart Failure | Congestive Heart Failure | CHF | Chronic Heart DiseaseUnited States
-
Heike Bischoff-FerrariRecruitingCardiovascular Diseases | Hypertension | Diabetes | Dementia | FrailtySwitzerland
-
Impulse DynamicsCompletedHeart Failure, DiastolicSweden, Italy, Czechia, Spain, Australia, Germany, Poland, Portugal
-
National Medical Research Center for Cardiology...Ministry of Health, Russian FederationCompletedHeart Failure | Atrial Fibrillation | Left Ventricular Ejection FractionRussian Federation
-
Impulse DynamicsRecruitingHeart Failure | Heart Failure With Preserved Ejection Fraction | Diastolic Heart Failure | Heart Failure With Mid Range Ejection Fraction | Heart Failure With Moderately Reduced Ejection FractionUnited States
-
Impulse DynamicsRecruitingHeart Failure | Arrhythmias, Cardiac | Ventricular Fibrillation | Ventricular Tachycardia | Implantable Defibrillator User | Heart Failure With Reduced Ejection Fraction | Ischemic Cardiomyopathy | Sudden Cardiac Arrest | Non-ischemic Cardiomyopathy | CCM TherapyUnited States
-
Impulse DynamicsCompletedNYHA Class III Heart Failure | NYHA Class IV Heart FailureUnited States, Germany, Czechia
-
TriFlo Cardiovascular, Inc.Not yet recruitingSymptomatic Severe Tricuspid RegurgitationItaly