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

NCT00187187 | Completed DMC

• 1 other identifier: G990333/SO28
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is either death or CHF hospitalization.

  The primary endpoint is either death or CHF hospitalization.

  All 600 enrolled patients will be followed to a common termination date at 2.5 years.

Study Arms (2)

Implantable Defibrillator (ICD) VVI-40

ACTIVE COMPARATOR

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) AAI-70

ACTIVE COMPARATOR

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)

Interventions

Implantable Defibrillator (ICD) DEVICE

Implantable Defibrillator (ICD)

Also known as: Implantable Defibrillator

Implantable Defibrillator (ICD) VVI-40

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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.

You may not qualify if:

• 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.,
• nd 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• University of Washington: collaborator

Related Publications (2)

• Wilkoff BL, Kudenchuk PJ, Buxton AE, Sharma A, Cook JR, Bhandari AK, Biehl M, Tomassoni G, Leonen A, Klevan LR, Hallstrom AP; DAVID II Investigators. The DAVID (Dual Chamber and VVI Implantable Defibrillator) II trial. J Am Coll Cardiol. 2009 Mar 10;53(10):872-80. doi: 10.1016/j.jacc.2008.10.057.

  PMID: 19264245 RESULT

• Kudenchuk PJ, Hallstrom AP, Herre JM, Wilkoff BL; DAVID II Investigators. Heart rate, pacing, and outcome in the Dual Chamber and VVI Implantable Defibrillator (DAVID) trials. Heart Rhythm. 2009 Aug;6(8):1129-35. doi: 10.1016/j.hrthm.2009.04.039. Epub 2009 May 20.

  PMID: 19632624 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Death, Sudden, Cardiac; Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Allfred P Hallstrom, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 4, 2019

Record last verified: 2019-02