MODULA-Study: Modul 10: Benefit of CRT-therapy in CRT-Patients With QRS-complex of 120 - 150 ms

Boston Scientific Corporation1 site in 1 country100 target enrollmentJune 2002

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Boston Scientific Corporation
Enrollment: 100
Locations: 1
Primary Endpoint: Observational: Benefit of CRT
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms.

Detailed Description

The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of \> 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

October 2007

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Eligibility Criteria

Inclusion Criteria

•Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
•New York Heart Association (NYHA) III
•Ejection fraction (EF) below 35%
•Optimised medical therapy
•QRS-complex above 120 ms