POWER (Pulse Width Optimized Waveform Evaluation Trial)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00311181
First received: April 3, 2006
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Defibrillation Thresholds (DFTs) (3.5 ms Waveform) [ Time Frame: Implant ] [ Designated as safety issue: No ]
  • DFT (2.5 ms Waveform) [ Time Frame: Implant ] [ Designated as safety issue: No ]
  • DFT (4.5 ms Waveform) [ Time Frame: Implant ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311181

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
St. Jude Medical
Investigators
Principal Investigator: Shephal Doshi, MD Pacific Heart Institute
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00311181     History of Changes
Other Study ID Numbers: CRD 324
Study First Received: April 3, 2006
Results First Received: July 24, 2011
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
ICD
Defibrillation
ULV
Tuned

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014