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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: CRT-P and CRT-D devices

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QRS 120-150 ms; Subjects with a QRS width between 120-150 ms	Behavioral: CRT-P and CRT-D devices
QRS >150 ms; Subjects with a QRS width >150 ms	Behavioral: CRT-P and CRT-D devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Observational: Benefit of CRT	12 month

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Guidant Corporation
• Investigators: Principal Investigator: Andreas Tiroke, MD, Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Study Completion (ACTUAL): October 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (ESTIMATE): September 16, 2005

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Version vom 05.08.2002