NCT00180401

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

First QC Date

September 12, 2005

Last Update Submit

February 17, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Observational: Benefit of CRT

    12 month

Study Arms (2)

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

Interventions

CRT-P and CRT-D devicesBEHAVIORAL
QRS 120-150 msQRS >150 ms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with CRT-P and atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Christian Albrecht Universität / Kardiologische Abteilung

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andreas Tiroke, MD

    Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

June 1, 2002

Study Completion

October 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

DE(1)