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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187187
First Posted: September 16, 2005
Last Update Posted: October 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Washington
Information provided by:
St. Jude Medical
  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
Ventricular Tachycardia Ventricular Fibrillation Sudden Cardiac Death Congestive Heart Failure Device: Implantable Defibrillator (ICD)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The primary endpoint is either death or CHF hospitalization. [ Time Frame: All 600 enrolled patients will be followed to a common termination date at 2.5 years. ]
    The primary endpoint is either death or CHF hospitalization.


Enrollment: 600
Study Start Date: June 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Implantable Defibrillator (ICD) VVI-40
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 (AAI-70)will not increase the rate of the combined endpoint of mortality or hospitalization for new or worsened heart failure, compared to patients with ventricular backup pacing (VVI-40).
Device: Implantable Defibrillator (ICD)
Implantable Defibrillator (ICD)
Other Name: Implantable Defibrillator
Active Comparator: Implantable Defibrillator (ICD) AAI-70
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 (AAI-70)will not increase the rate of the combined endpoint of mortality or hospitalization for new or worsened heart failure, compared to patients with ventricular backup pacing (VVI-40).
Device: Implantable Defibrillator (ICD)
Implantable Defibrillator (ICD)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187187


Sponsors and Collaborators
St. Jude Medical
University of Washington
Investigators
Principal Investigator: Allfred P Hallstrom, PhD University of Washington
  More Information

Publications:
Responsible Party: Heidi Hinrichs, Director of Clinical Operations, St. Jude Medical CRMD
ClinicalTrials.gov Identifier: NCT00187187     History of Changes
Other Study ID Numbers: G990333/SO28
First Submitted: September 10, 2005
First Posted: September 16, 2005
Last Update Posted: October 22, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Death
Death, Sudden, Cardiac
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden