NCT00180596

Brief Summary

The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication

Trial Health

90
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_4 heart-failure

Geographic Reach
2 countries

2 active sites

Status
completed

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

January 1, 2000

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

January 6, 2016

Status Verified

June 1, 2005

First QC Date

September 15, 2005

Last Update Submit

January 5, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Improvement in functional capacity as measured by a six-minute walk test at 6 months

Secondary Outcomes (1)

  • Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months

Interventions

Contak heart failure devicesDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- NYHA Class III and IV with EF \< 35%; Optimal individual drug therapy in 2 weeks prior to enrollment including ACE inhibitors; beta blockers and diuretics unless not tolerated

You may not qualify if:

  • Reduced life expectancy of \< 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guidant Corporation, , , Belgium

Diegem, 1831, Belgium

Location

Medizinische Klinik I, University RWTH Aachen

Aachen, 52057, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • P HANRATH, MD

    Medizinische Klinik I, University RWTH Aachen, Pauwelsstr. 30, 52057 Aachen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

January 1, 2000

Study Completion

September 1, 2005

Last Updated

January 6, 2016

Record last verified: 2005-06

Locations

DE(1)BE(1)