PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180596

Enrollment

262

Registered

2005-09-16

Start date

2000-01-31

Completion date

2005-09-30

Last updated

2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICEContak heart failure devices

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement in functional capacity as measured by a six-minute walk test at 6 months	—

Secondary

Measure	Time frame
Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months	—

Countries

Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026