Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180596
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2005-09-15
Brief Title:
PACMAN - PAcing for CardioMyopathies a EuropeAN Study
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Pacing for Cardiomyopathies a European Study- A Therapy Acceptance Study
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None