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)
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180401
First received: September 12, 2005
Last updated: April 22, 2009
Last verified: April 2009
  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 4

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014