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

Terminated

• Conditions: Heart Failure
• Interventions: Behavioral: CRT-P and CRT-D devices

• Registration Number: NCT00180401
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

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 Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Completion: 2007-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QRS 120-150 ms	CRT-P and CRT-D devices	Subjects with a QRS width between 120-150 ms
QRS >150 ms	CRT-P and CRT-D devices	Subjects with a QRS width \>150 ms

Primary Outcome Measures

Name	Time	Method
Observational: Benefit of CRT	12 month

Trial Locations

Locations (1)

Klinikum der Christian Albrecht Universität / Kardiologische Abteilung; 🇩🇪 Kiel, Germany