Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187187
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2005-09-10
Brief Title:
DAVID II Dual Chamber and VVI Implantable Defibrillator DAVID Trial II
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
DAVID II Dual Chamber and VVI Implantable Defibrillator DAVID Trial II
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAVIDII
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
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 rate of the combined endpoint of mortality or hospitalization for new or worsened heart failure compared to patients with ventricular backup pacing VVI and that AAI pacing will result in a reduction of 0425 years in median event-free survival compared to VVI pacing
Enrollment and Randomization
A total of 600 patients have been enrolled and randomized All patients previously enrolled in the VVI arm of the DAVID Trial who were hemodynamically stable in the VVI-40 programmed mode and willing to participate have been randomized in equal numbers into the study New patients not previously randomized in DAVID have also been enrolled and similarly randomized The randomization was stratified for investigational site for previous randomization in DAVID vs being newly-enrolled for a history of CHF and among the new enrollees for primary versus preventive eligibility criteria
Patients were enrolled with the same indications used in the DAVID Trial including MADIT II indications with the exception that any patient in class III heart failure must have been on optimal heart failure therapy for at least 3 months prior to enrollment and randomization
Any planned cardiac surgery ablation endocardial resection valve aneurysmectomy revascularization must have been completed before randomization All patients have received commercially available St Jude dual chamber ICD systems
Blinding
Patients have not be told to which pacing mode VVI or AAI they have been assigned ie they will be blinded in order to reduce the potential for patient generated bias in the quality of life assessments which are part of the study
Crossover
All patients will remain in the study with the device programmed according to their randomization assignment from the point of randomization to the end of follow-up No crossover from one pacing mode to the other is permitted even after a hospital admission for congestive heart failure until the reason for the requested crossover is reviewed and permission is obtained from the University of Washington Clinical Trials Center to change pacing mode
Optimal CHF Pharmacologic Therapy
Optimal CHF Pharmacologic Therapy in the study consists of digoxin diuretics angiotensin-converting enzyme ACE inhibitors and beta-blockers Treatment during the study adheres to the Heart Failure Society of America HFSA Practice Guidelines Heart Failure symptoms are treated by adjustment of both the rate and rate response of the pacemaker and the medications
Primary Endpoint
The primary endpoint is either death or CHF hospitalization The determination of CHF hospitalization will be made by an Events Committee based on review of the hospital records blinded as to treatment arm
Secondary endpoints include
Appropriate ICD therapy--ICD shocks plus Antitachycardia PacingATPevents
Inappropriate ICD therapy any therapy deemed not related to Ventricular Tachycardia VT or Ventricular Fibrillation VF
Quality of Life SF-36 MLHF VAS
Follow-up
Patients will be followed at 3-month intervals The patients are also instructed to call their investigational center any time they receive an ICD shock therapy delivery in order to have an ICD interrogationdownload of the devices memory performed
Data Items Collected
Standard demographics clinical histories and a QoL assessment were obtained at baseline During the follow-up phase routine clinical data is obtained every 3 months Quality of life assessments are be repeated at 6 months Events adverse symptoms hospitalization deathtrigger more extensive data collection including in particular 1all ICD printouts 2detailed hospital records for all CHF hospitalizations and patient records for all deaths
Enrollment and Randomization
A total of 600 patients have been enrolled and randomized All patients previously enrolled in the VVI arm of the DAVID Trial who were hemodynamically stable in the VVI-40 programmed mode and willing to participate have been randomized in equal numbers into the study New patients not previously randomized in DAVID have also been enrolled and similarly randomized The randomization was stratified for investigational site for previous randomization in DAVID vs being newly-enrolled for a history of CHF and among the new enrollees for primary versus preventive eligibility criteria
Patients were enrolled with the same indications used in the DAVID Trial including MADIT II indications with the exception that any patient in class III heart failure must have been on optimal heart failure therapy for at least 3 months prior to enrollment and randomization
Any planned cardiac surgery ablation endocardial resection valve aneurysmectomy revascularization must have been completed before randomization All patients have received commercially available St Jude dual chamber ICD systems
Blinding
Patients have not be told to which pacing mode VVI or AAI they have been assigned ie they will be blinded in order to reduce the potential for patient generated bias in the quality of life assessments which are part of the study
Crossover
All patients will remain in the study with the device programmed according to their randomization assignment from the point of randomization to the end of follow-up No crossover from one pacing mode to the other is permitted even after a hospital admission for congestive heart failure until the reason for the requested crossover is reviewed and permission is obtained from the University of Washington Clinical Trials Center to change pacing mode
Optimal CHF Pharmacologic Therapy
Optimal CHF Pharmacologic Therapy in the study consists of digoxin diuretics angiotensin-converting enzyme ACE inhibitors and beta-blockers Treatment during the study adheres to the Heart Failure Society of America HFSA Practice Guidelines Heart Failure symptoms are treated by adjustment of both the rate and rate response of the pacemaker and the medications
Primary Endpoint
The primary endpoint is either death or CHF hospitalization The determination of CHF hospitalization will be made by an Events Committee based on review of the hospital records blinded as to treatment arm
Secondary endpoints include
Appropriate ICD therapy--ICD shocks plus Antitachycardia PacingATPevents
Inappropriate ICD therapy any therapy deemed not related to Ventricular Tachycardia VT or Ventricular Fibrillation VF
Quality of Life SF-36 MLHF VAS
Follow-up
Patients will be followed at 3-month intervals The patients are also instructed to call their investigational center any time they receive an ICD shock therapy delivery in order to have an ICD interrogationdownload of the devices memory performed
Data Items Collected
Standard demographics clinical histories and a QoL assessment were obtained at baseline During the follow-up phase routine clinical data is obtained every 3 months Quality of life assessments are be repeated at 6 months Events adverse symptoms hospitalization deathtrigger more extensive data collection including in particular 1all ICD printouts 2detailed hospital records for all CHF hospitalizations and patient records for all deaths
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None