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

February 17, 2017 updated by: Boston Scientific Corporation

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Version vom 05.08.2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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