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

This study has been terminated.

( no longer interest from medical community )

First Received on September 12, 2005. Last Updated on April 22, 2009 History of Changes

Sponsor:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180401

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Behavioral: CRT-P and CRT-D devices	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 ms

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Estimated Enrollment:	100
Study Start Date:	June 2002
Study Completion Date:	October 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Exclusion Criteria:

Patients with CRT-P and atrial fibrillation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180401

Locations

Germany
Klinikum der Christian Albrecht Universität / Kardiologische Abteilung
Kiel, Germany, 24105

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Andreas Tiroke, MD

Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00180401 History of Changes
Other Study ID Numbers:	Version vom 05.08.2002
Study First Received:	September 12, 2005
Last Updated:	April 22, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012