PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

Phase 4

Completed

• Conditions: Heart Failure

• Registration Number: NCT00180596
• Lead Sponsor: 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

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 Timeline

• Study Start: 2000-01
• Status Verified: 2005-06
• Study Completion: 2005-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in functional capacity as measured by a six-minute walk test at 6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months

Trial Locations

Locations (2)

Medizinische Klinik I, University RWTH Aachen; 🇩🇪 Aachen, Germany

Guidant Corporation, , , Belgium; 🇧🇪 Diegem, Belgium