PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

Heart Failure Clinical Trial

Official title: Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

• NCT number: NCT00180596
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Completed
• Phase: Phase 4
• Start date: January 2000
• Completion date: September 2005