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PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

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ClinicalTrials.gov Identifier: NCT00180596
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 6, 2016
Information provided by (Responsible Party):
Boston Scientific Corporation

September 15, 2005
September 16, 2005
January 6, 2016
January 2000
Not Provided
Improvement in functional capacity as measured by a six-minute walk test at 6 months
Same as current
Complete list of historical versions of study NCT00180596 on ClinicalTrials.gov Archive Site
Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months
Same as current
Not Provided
Not Provided
PACMAN - PAcing for CardioMyopathies, a EuropeAN Study
Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study
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
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.
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Heart Failure
Device: Contak heart failure devices
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2005
Not Provided

Inclusion Criteria:

- 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

Exclusion Criteria:

  • Reduced life expectancy of < 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany
Not Provided
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Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: P HANRATH, MD Medizinische Klinik I, University RWTH Aachen, Pauwelsstr. 30, 52057 Aachen, Germany
Boston Scientific Corporation
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP