This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: September 15, 2005
Last updated: January 5, 2016
Last verified: June 2005
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 Intervention Phase
Heart Failure Device: Contak heart failure devices Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Improvement in functional capacity as measured by a six-minute walk test at 6 months

Secondary Outcome Measures:
  • Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months

Estimated Enrollment: 262
Study Start Date: January 2000
Estimated Study Completion Date: September 2005
Detailed Description:
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180596

Guidant Corporation, , , Belgium
Diegem, Belgium, 1831
Medizinische Klinik I, University RWTH Aachen
Aachen, Germany, 52057
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: P HANRATH, MD Medizinische Klinik I, University RWTH Aachen, Pauwelsstr. 30, 52057 Aachen, Germany
  More Information

Responsible Party: Boston Scientific Corporation Identifier: NCT00180596     History of Changes
Other Study ID Numbers: PACMAN-1099
Study First Received: September 15, 2005
Last Updated: January 5, 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on July 21, 2017