NCT00387803

Brief Summary

The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
581

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 1998

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

February 1, 1998

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
Last Updated

January 25, 2007

Status Verified

January 1, 2007

First QC Date

October 11, 2006

Last Update Submit

January 23, 2007

Conditions

Heart Failure, CongestiveVentricular FibrillationTachycardia, Ventricular

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia

Secondary Outcomes (5)

  • Peak VO2

  • NYHA Class

  • Six minute walk distance

  • Quality of life

  • Echocardiographic measures

Interventions

Cardiac Resynchronization Therapy with DefibrillationDEVICE

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic heart failure
  • Left ventricular ejection fraction \<= 35%
  • QRS width \>= 120 ms
  • Indicated for an implantable cardioverter defibrillator

You may not qualify if:

  • Indicated for a pacemaker
  • Atrial tachyarrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple locations

Saint Paul, Minnesota, 55112, United States

Location

Related Publications (1)

  • Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.

    PMID: 14563591RESULT

MeSH Terms

Conditions

Heart FailureVentricular FibrillationTachycardia, Ventricular

Interventions

Cardiac Resynchronization TherapyElectric Countershock

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Steven Higgins, MD

    Scripps Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Leslie A Saxon, MD

    University of California San Francisco Medical Center

    PRINCIPAL INVESTIGATOR

  • John Boehmer, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

  • Teresa De Marco, MD

    University of California San Francisco Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 13, 2006

Study Start

February 1, 1998

Study Completion

August 1, 2001

Last Updated

January 25, 2007

Record last verified: 2007-01

Locations

US(1)