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CompletedNCT00387803Updated Jan 25, 2007

Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

A Phase 2/3 interventional study of Cardiac Resynchronization Therapy with Defibrillation in Heart Failure, Congestive, Ventricular Fibrillation and Tachycardia, Ventricular, sponsored by Boston Scientific Corporation. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2007-01-25.

Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
581
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.

02

Conditions studied

  • Heart Failure, Congestive
  • Ventricular Fibrillation
  • Tachycardia, Ventricular
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 581 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Indicated for a pacemaker
  • Atrial tachyarrhythmias
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
581 participants

Interventions

  • DeviceCardiac Resynchronization Therapy with Defibrillation
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Peak VO2

  2. NYHA Class

  3. Six minute walk distance

  4. Quality of life

  5. Echocardiographic measures

07

Study locations

1 site
  • Multiple locations
    Saint Paul, Minnesota 55112, United States
08

References and documents

Publications

  • 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. PubMed 14563591 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00387803
Lead sponsor
Boston Scientific Corporation
First posted
Oct 13, 2006
Start date
Feb 1998
Completion
Aug 2001
Last update
Jan 25, 2007

Study contacts

Steven Higgins, MD
principal investigator · Scripps Memorial Hospital
Leslie A Saxon, MD
principal investigator · University of California San Francisco Medical Center
John Boehmer, MD
principal investigator · Milton S. Hershey Medical Center
Teresa De Marco, MD
principal investigator · University of California San Francisco Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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