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CLINICAL RESEARCH: NORMAL QRS DURATION AND RESYNCHRONIZATION

Electrical Signals Applied During the Absolute Refractory Period

An Investigational Treatment for Advanced Heart Failure in Patients With Normal QRS Duration

Thomas Lawo, MD^_*, Martin Borggrefe, MD, Christian Butter, MD, Gerhard Hindricks, MD, Herwig Schmidinger, MD^||, Yuval Mika, PhD^¶, Daniel Burkhoff, MD, PhD^¶,#, Carlo Pappone, MD, PhD^_** and Hani N. Sabbah, PhD^,_*

^_* Berufgenossenschaftliche Kliniken Bergmannnsheil, Bochum, Germany
Fakultät für klinische Medizin der Universität Heidelberg, Mannheim, Germany
Heart Center Brandenburg Bernau/Berlin, Bernau, Germany
Herzzentrum der Universität Leipzig, Leipzig, Germany
^|| Department of Cardiology, University Clinic for Internal Medicine II, Vienna, Austria
^¶ IMPULSE Dynamics USA, Orangeburg, New York
^# Columbia University, New York, New York
^_** Fondazione Centro S. Raffaele de Monte Tabor, Milano, Italy
Henry Ford Health System, Detroit, Michigan

Manuscript received February 28, 2005; revised manuscript received April 11, 2005, accepted May 10, 2005.

^_* Reprint requests and correspondence: Dr. Hani N. Sabbah, Division of Cardiovascular Medicine, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, Michigan 48202 (Email: hsabbah1{at}hfhs.org).

Cardiac resynchronization therapy has been shown to be an effective treatment for patients with systolic ventricular dysfunction, prolonged (>120 ms) QRS duration, and New York Heart Association (NYHA) functional class III or IV symptoms despite optimal medical therapy. However, studies show that a majority of heart failure patients have QRS duration <120 ms. We have been investigating the potential utility of cardiac contractility modulating (CCM) signals as a treatment option for such patients. Cardiac contractility modulating signals are non-excitatory signals applied during the absolute refractory period using a pacemaker-like device that connects to the heart with pacemaker leads. Acute studies carried out in animals and humans with heart failure suggest that CCM signals can enhance the strength of left ventricular contraction. Results of initial long-term studies designed mainly to demonstrate feasibility and provide preliminary indication of safety in patients with medically refractory NYHA functional class III heart failure are summarized. The results of these preclinical and clinical studies formed the basis for proceeding with two prospective, randomized clinical studies currently underway to definitively test the safety and efficacy of this treatment.

Abbreviations and Acronyms   CCM = cardiac contractility modulation   CHF = chronic heart failure   CRT = cardiac resynchronization therapy   EF = ejection fraction   ICD = implantable cardioverter-defibrillator   LV = left ventricular   MLWHFQ = Minnesota Living With Heart Failure Questionnaire   MVO2 = myocardial oxygen consumption   NYHA = New York Heart Association

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