POWER (Pulse Width Optimized Waveform Evaluation Trial)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00311181
• Collaborator: (none)
• Enrollment: 217
• Locations: 2
• Arm: 1
• Duration (Months): 20
• Patients Per Site: 108.5
• Patients Per Site Per Month: 5.4

Study Details

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
• 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: Aug 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 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) [Implant]

2. DFT (2.5 ms Waveform) [Implant]

3. DFT (4.5 ms Waveform) [Implant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Baptist Medical Center Montclair	Birmingham	Alabama	United States	35212
2	Pacific Heart Institute	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00311181
• Other Study ID Numbers: CRD 324
• First Posted: Apr 5, 2006
• Last Update Posted: Feb 20, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: ICD; Defibrillation; ULV; Tuned
• Additional relevant MeSH terms: Death, Sudden, Cardiac; Death

Study Results

Participant Flow

Arm/Group Title	Group 1
Arm/Group Description
Period Title: Overall Study
STARTED	217
COMPLETED	121
NOT COMPLETED	96

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description
Overall Participants	217
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	88 40.6%
>=65 years	129 59.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (14)
Sex: Female, Male (Count of Participants)
Female	57 26.3%
Male	160 73.7%
Region of Enrollment (participants) [Number]
United States	217 100%

Outcome Measures

1. Primary Outcome

Title	Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
Time Frame	Implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description
Measure Participants	121
Mean (Standard Error) [Volts]	427 (11)

2. Primary Outcome

Title	DFT (2.5 ms Waveform)
Time Frame	Implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description
Measure Participants	121
Mean (Standard Error) [Volts]	454 (11)

3. Primary Outcome

Title	DFT (4.5 ms Waveform)
Time Frame	Implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description
Measure Participants	121
Mean (Standard Error) [Volts]	435 (11)

Adverse Events

Arm/Group Title	Group 1
Arm/Group Description
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/217 (0%)
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/217 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.