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NCT00180401 Clinical Trial

MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00180401
Other study ID # Version vom 05.08.2002
Secondary ID
Status Terminated
Phase N/A
First received September 12, 2005
Last updated February 17, 2017
Start date June 2002
Est. completion date October 2007

Study information
Verified date February 2017
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Exclusion Criteria:

- Patients with CRT-P and atrial fibrillation

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• CRT-P and CRT-D devices

Locations
Country Name City State
Germany Klinikum der Christian Albrecht Universität / Kardiologische Abteilung Kiel

Sponsors (2)
Lead Sponsor Collaborator
Boston Scientific Corporation Guidant Corporation

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Observational: Benefit of CRT 12 month
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