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OpenTrials
Completed

NCT Number: NCT00387803

Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

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.

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Key information

Conditions

Heart Failure, Congestive Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Multiple locations

Saint Paul, Minnesota, 55112, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Indicated for a pacemaker
  • Atrial tachyarrhythmias

Treatment and study plan

Cardiac resynchronization therapy with defibrillation

Device

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

VENTAK CHF/CONTAK CD Biventricular Pacing Study

Important dates

Study start
1998
Study completion
2001
First posted
Oct 13, 2006
Registry last updated
Jan 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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