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PACMAN

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180596
First received: September 15, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Guidant 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180596

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

No publications provided

ClinicalTrials.gov Identifier: NCT00180596     History of Changes
Other Study ID Numbers: PACMAN-1099
Study First Received: September 15, 2005
Last Updated: September 15, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013