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)
Information provided by:
First received: September 12, 2005
Last updated: April 22, 2009
Last verified: April 2009
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.
Behavioral: CRT-P and CRT-D devices
||Observational Model: Case Control
Time Perspective: Prospective
||MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 ms
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Patients with CRT-P and atrial fibrillation
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
|Klinikum der Christian Albrecht Universität / Kardiologische Abteilung
|Kiel, Germany, 24105 |
||Andreas Tiroke, MD
||Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany
No publications provided
ClinicalTrials.gov processed this record on March 03, 2015
History of Changes
|Other Study ID Numbers:
||Version vom 05.08.2002
|Study First Received:
||September 12, 2005
||April 22, 2009
||Germany: Federal Institute for Drugs and Medical Devices