PACMAN - Full Text View - ClinicalTrials.gov

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 IV

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment

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

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

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

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 27, 2008

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180596