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

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187187
First received: September 10, 2005
Last updated: October 20, 2010
Last verified: October 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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. ] [ Designated as safety issue: Yes ]
    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)
Other Name: Implantable Defibrillator (ICD)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 10, 2005
Last Updated: October 20, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014