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DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)

This study is ongoing, but not recruiting participants.

Sponsored by: St. Jude Medical
Information provided by: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00187187
  Purpose

The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will not increase the rate of the combined endpoint of mortality or hospitalization for new or worsened heart failure as compared to patients with ventricular backup pacing.


Condition Intervention Phase
Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Congestive Heart Failure
Device: Implantable Defibrillator (ICD)
Phase IV

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Cardiac Arrest    Heart Failure    Pacemakers and Implantable Defibrillators   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • All 600 enrolled patients will be followed to a common termination date at 2.5 years.

Estimated Enrollment:   600
Study Start Date:   June 2003

Show detailed description  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

I. DAVID I patients enrolled in the VVI-40 who are hemodynamically stable.

II. Patients with an LVEF 0.40 considered for ICD therapy because of one of the following primary, spontaneously occurring, sustained events within the last 6 weeks prior to enrollment:

  • VF arrest (ACC/AHA indication Class 1-1),
  • VT with syncope (ACC/AHA indication Class 1-1 or 1-2),
  • Non-syncopal sustained VT with significant cardiac symptoms or BP < 80 (ACC/AHA indication Class 1-2, IIb-4),

OR

III. Patients considered for ICD therapy because of one of the following:

  • LVEF < 0.40 with inducible VT or VF within 6 weeks prior to randomization (with or without spontaneous arrhythmia), or
  • LVEF < 0.30 with coronary artery disease, > 1 month from a myocardial infarction, and > 3 months from bypass surgery or percutaneous coronary intervention.

If the ICD was already implanted at time of consideration for enrollment, the device must have been programmed in the VVI mode since implant.

Exclusion Criteria:

  • NYHA CHF Class III unless on optimal heart failure therapy for at least 3 months prior to enrollment,
  • NYHA CHF Class IV,
  • Reversible causes of the VT/VF event,
  • Permanent pacemaker,
  • First degree AV block with PR interval of more than 240 ms.,
  • 2nd or 3rd or advanced degree heart block,
  • Symptomatic bradycardia,
  • Pre-existing endocardial pacing leads,
  • Permanent atrial fibrillation (>= 6 months or unknown duration),
  • Patient awaiting a cardiac transplant,
  • Life expectancy <1 year,
  • Frequent uncontrolled atrial tachyarrhythmia, or
  • Inability to obtain informed consent.
  Contacts and Locations

No Contacts or Locations Provided
  More Information

Study ID Numbers:   G990333/SO28
First Received:   September 10, 2005
Last Updated:   September 10, 2005
ClinicalTrials.gov Identifier:   NCT00187187
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Death
Heart Failure
Heart Diseases
Tachycardia
Death, Sudden
Paroxysmal ventricular fibrillation
Heart Arrest
Death, Sudden, Cardiac
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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