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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00311181 |
The objective of this study is to compare the ULV/DFT 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: ICD, CRT-D |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study |
Official Title: | Phase 4 Study That Compares the DFT Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms |
Estimated Enrollment: | 120 |
Study Start Date: | August 2006 |
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 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%.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Baptist Medical Center Montclair | |
Birmingham, Alabama, United States, 35212 | |
United States, California | |
Pacific Heart Institute | |
Santa Monica, California, United States, 90404 |
Principal Investigator: | Shephal Doshi, MD | Pacific Heart Institute |
Study ID Numbers: | CRD 324 |
Study First Received: | April 3, 2006 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00311181 History of Changes |
Health Authority: | United States: Institutional Review Board |
ICD Defibrillation ULV Tuned |
Death Heart Diseases Death, Sudden Heart Arrest Death, Sudden, Cardiac |
Death Pathologic Processes Heart Diseases Death, Sudden |
Cardiovascular Diseases Heart Arrest Death, Sudden, Cardiac |