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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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QRS 120-150 ms

Subjects with a QRS width between 120-150 ms

CRT-P and CRT-D devices

Intervention Type BEHAVIORAL

QRS >150 ms

Subjects with a QRS width \>150 ms

CRT-P and CRT-D devices

Intervention Type BEHAVIORAL

Interventions

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CRT-P and CRT-D devices

Intervention Type BEHAVIORAL

Eligibility Criteria

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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