POWER (Pulse Width Optimized Waveform Evaluation Trial)
Primary Purpose
Sudden Cardiac Death
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
Sponsored by
About this trial
This is an interventional treatment trial for Sudden Cardiac Death focused on measuring ICD, Defibrillation, ULV, Tuned
Eligibility Criteria
Inclusion Criteria: Patient is a candidate for ICD/CRT-D implantation. Patient has a compatible transvenous defibrillation lead system. Patient has had an echocardiogram, MUGA, or cath procedure within 6 months of ICD/CRT-D implant. Patient is able to tolerate ULV guided DFT testing. Exclusion Criteria: Patient has a mechanical valve in the tricuspid position. Patient has epicardial defibrillation electrodes. Patient is pregnant. Patient is less than 18 years old.
Sites / Locations
- Baptist Medical Center Montclair
- Pacific Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2.5/3.5/4.5 ms defibrillation waveform
Arm Description
Outcomes
Primary Outcome Measures
Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
DFT (2.5 ms Waveform)
DFT (4.5 ms Waveform)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311181
Brief Title
POWER (Pulse Width Optimized Waveform Evaluation Trial)
Official Title
Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms. This comparison will result in identifying the optimal membrane time constant when programming the "tuned" defibrillation waveform.
Detailed Description
Sudden cardiac death (SCD) continues to be a significant cause of cardiac mortality with annual deaths ranging from 250,000 to 400,000 in the United States. Accordingly, implantable cardioverter-defibrillators (ICD's) have proven to be an important therapeutic option for patients susceptible to SCD. Successful therapy and generator longevity are greatly dependent on proper defibrillation threshold (DFT) determination.
All modern ICD's utilize a biphasic waveform for defibrillation. It has been clearly shown that biphasic waveforms reduce the energy required for internal defibrillation of the heart. However, there is no consensus on which pulse widths are best for defibrillation.
St. Jude Medical ICD's (implantable cardioverter defibrillators) have programmable pulse widths, which allow the physician multiple options in dealing with ICD patients. By implanting ICD's with programmable pulse widths, this study utilizes the Tissue RC Resistance/Capacitance) model to try to identify the optimal pulse widths.
To determine the efficacy of an optimal membrane time constant estimate for the "tuned" waveform, defibrillation testing must be performed. Upper limit of vulnerability (ULV) has been proposed as an alternative means of predicting the DFT and it has been shown that ULV guided DFT testing can achieve a defibrillation success rate of 95%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death
Keywords
ICD, Defibrillation, ULV, Tuned
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2.5/3.5/4.5 ms defibrillation waveform
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
Intervention Description
Patients that are indicated for an ICD or CRT-D receive one of these devices.
Primary Outcome Measure Information:
Title
Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
Time Frame
Implant
Title
DFT (2.5 ms Waveform)
Time Frame
Implant
Title
DFT (4.5 ms Waveform)
Time Frame
Implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is a candidate for ICD/CRT-D implantation.
Patient has a compatible transvenous defibrillation lead system.
Patient has had an echocardiogram, MUGA, or cath procedure within 6 months of ICD/CRT-D implant.
Patient is able to tolerate ULV guided DFT testing.
Exclusion Criteria:
Patient has a mechanical valve in the tricuspid position.
Patient has epicardial defibrillation electrodes.
Patient is pregnant.
Patient is less than 18 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shephal Doshi, MD
Organizational Affiliation
Pacific Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Medical Center Montclair
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35212
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
POWER (Pulse Width Optimized Waveform Evaluation Trial)
We'll reach out to this number within 24 hrs