PACMAN - PAcing for CardioMyopathies, a EuropeAN Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication
Condition or disease
Device: Contak heart failure devices
Heart Failure is a syndrome that affects millions of patients in Europe with over half a million new cases reported annually. Drug therapy had been the conventional treatment of choice until the emergence of cardiac resynchronization therapy (CRT) where biventricular pacing can be delivered to the heart through a pacemaker or implantable cardioverter defibrillator. This study was designed to assess the effect of CRT on patients optimized on conventional heart failure medication including diuretics, beta blockers and ACE inhibitors. The effect of CRT was evaluated by comparison of 6 minute walk performance, Quality of Life and NHYA class after 6 months with CRT therapy either programmed ON or OFF. In addition, evaluation of the incidence of adverse events (predefined as ventricular arrhythmias, hospitalizations, drop-outs, complications and patient deaths) was done between groups at 6 months. Patients were all programmed ON after 6 months and data was collected for an additional 6 months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
- NYHA Class III and IV with EF < 35%; Optimal individual drug therapy in 2 weeks prior to enrollment including ACE inhibitors; beta blockers and diuretics unless not tolerated
Reduced life expectancy of < 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter