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

Boston Scientific

Status: Terminated

Conditions: Heart Failure

Treatments: Behavioral: CRT-P and CRT-D devices

Study type: Observational

Funder types: Industry

Identifiers

NCT00180401

Version vom 05.08.2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

QRS 120-150 ms

Description:

Subjects with a QRS width between 120-150 ms

Treatment:

Behavioral: CRT-P and CRT-D devices

QRS >150 ms

Description:

Subjects with a QRS width \>150 ms

Treatment:

Behavioral: CRT-P and CRT-D devices