Status:
COMPLETED
DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
University of Washington
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
Phase:
NA
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 r...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00187187
Start Date
June 1 2003
End Date
September 1 2007
Last Update
February 4 2019
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