»Cardiovascular Clinical Trials 

Protocol
            
802972

Title
            
Evaluation of the safety and effectiveness of an experimental medical device in patients with moderate to severe heart failure.

Official Title
            
Evaluation of the Safety and Efficacy of the OPTIMIZER III System with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction: FIX-HF-5 (Protocol IDPT- 2003-07-C; FIX-HF-5 revised 01/18/11)

Investigator
            
Kent Volosin, MD

Status
            
No longer recruiting

Why is this study being done?
            
This research is being conducted to evaluate the safety and effectiveness of an experimental medical device called the OPTIMIZER System in patients with moderate to severe heart failure. The experimental treatment delivered by the OPTIMIZERâ„¢ System for stimulating the heart muscle with an electrical signal is called cardiac contractility modulation (CCM) treatment. The OPTIMIZER system is an implantable device. It has two main parts: the device and leads. The device has the generator, a rechargeable battery pack and electrical circuitry. The device is about the size of a deck of playing cards, and is surgically implanted through a small incision into the upper chest/shoulder area.

Who is eligible to participate in this study?
            Inclusion
  • NYHA Class III or IV heart failure
  • EF less than or equal to 35%
  • Appropriate and stable drug therapy for CHF
            Exclusion
  • Patients in whom biventricular pacing therapy is indicated
  • Correctable cause of heart failure
  • Clinically significant angina
  • Hospitalization for heart failure which required IV inotropic support within 30 days prior to enrollment or implantation
  • PR interval greater than 275 milliseconds
  • Permanent or persistent atrial flutter/fibrillation or cardioversion within 30 days prior to enrollment
  • CABG within 90 days or PTCA within 30 days prior to enrollment (or currently scheduled)
  • MI within 90 days prior to enrollment
  • Ability to exercise is limited by non-HF conditions
  • Unable to complete 6-minute walk or CPX testing

Age range?
            From:
18

What is involved with this study?
            
The study will be divided into three parts:
  • Screening/baseline evaluation, which will include a physical exam, medical history, Electrocardiogram (EKG), Echocardiogram (ECHO), patient questionnaires, Six minute walk, Cardiopulmonary Stress Test, and a 24 hour Holter monitoring test (about 10-15 minutes to set up and then worn for 24 hours).
  • Randomization to the OPTIMIZER device implantation procedure or control
  • Twelve-month follow-up period.

How long will this study run?
            
Each subject will be in the study for approximately 13 months.

Who can I contact for additional information on this trial?
            Name:
Susanne Donovan, RN, MS
            Phone:
(215)662-9084
            Email:
susanne.donovan@uphs.upenn.edu
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