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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
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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 Intervention/treatment Phase
Heart Failure Device: Contak heart failure devices Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study
Study Start Date : January 2000
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180596


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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180596     History of Changes
Other Study ID Numbers: PACMAN-1099
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: June 2005

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases