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| Sponsor: | St. Jude Medical |
|---|---|
| Collaborator: |
University of Washington |
| 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 |
|---|---|
|
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) |
| 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 |
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
| 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 |
|
Heart Failure Tachycardia Ventricular Fibrillation Tachycardia, Ventricular Death, Sudden, Cardiac Death |
Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Heart Arrest Death, Sudden |