POWER (Pulse Width Optimized Waveform Evaluation Trial)

• ClinicalTrials.gov Identifier: NCT00311181
• Recruitment Status: Completed
• First Posted: April 5, 2006
• Results First Posted: August 30, 2012
• Last Update Posted: February 20, 2019
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

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.

Condition or disease	Intervention/treatment	Phase
Sudden Cardiac Death	Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)	Phase 4

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%.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms
• Study Start Date: August 2006
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2.5/3.5/4.5 ms defibrillation waveform	Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D); Patients that are indicated for an ICD or CRT-D receive one of these devices.

Outcome Measures

Primary Outcome Measures :

1. Defibrillation Thresholds (DFTs) (3.5 ms Waveform) [ Time Frame: Implant ]
2. DFT (2.5 ms Waveform) [ Time Frame: Implant ]
3. DFT (4.5 ms Waveform) [ Time Frame: Implant ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

Baptist Medical Center Montclair

Birmingham, Alabama, United States, 35212

United States, California

Pacific Heart Institute

Santa Monica, California, United States, 90404

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Principal Investigator: Shephal Doshi, MD; Pacific Heart Institute

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00311181
• Other Study ID Numbers: CRD 324
• First Posted: April 5, 2006
• Results First Posted: August 30, 2012
• Last Update Posted: February 20, 2019
• Last Verified: February 2019

Keywords provided by Abbott Medical Devices:

ICD; Defibrillation; ULV; Tuned

Additional relevant MeSH terms:

Death, Sudden, Cardiac; Death; Pathologic Processes; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden