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

Boston Scientific Corporation100 enrolled

Overview

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.

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

100

Conditions

Heart Failure

Interventions

CRT-P and CRT-D devicesBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum der Christian Albrecht Universität / Kardiologische Abteilung

Kiel, Germany

Outcomes

Primary Outcomes

Observational: Benefit of CRT

Time frame: 12 month

Data from ClinicalTrials.gov

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