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| 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 |
| 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) |
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2003 |
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
OR
III. Patients considered for ICD therapy because of one of the following:
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:
Contacts and Locations
More Information
| Study ID Numbers: | G990333/SO28 |
| Study First Received: | September 10, 2005 |
| Last Updated: | September 10, 2005 |
| ClinicalTrials.gov Identifier: | NCT00187187 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Paroxysmal Ventricular Fibrillation Death Heart Failure Heart Diseases Tachycardia Death, Sudden |
Heart Arrest Death, Sudden, Cardiac Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
|
Death Heart Failure Pathologic Processes Heart Diseases Tachycardia Death, Sudden |
Heart Arrest Cardiovascular Diseases Death, Sudden, Cardiac Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |