Sudden Cardiac DeathPhase 4NCT00311181
POWER (Pulse Width Optimized Waveform Evaluation Trial)
A Phase 4 study testing Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D) in people with Sudden Cardiac Death, run by Abbott Medical Devices at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Apr 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient has a mechanical valve in the tricuspid position.
- Patient has epicardial defibrillation electrodes.
- Patient is pregnant.
- Patient is less than 18 years old.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baptist Medical Center Montclair
Birmingham, Alabama, 35212
Pacific Heart Institute
Santa Monica, California, 90404
About this study
Official title: Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms
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.
Read the 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%.
- Conditions
- Sudden Cardiac Death
- Being tested
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
- Keywords
- ICD, Defibrillation, ULV, Tuned
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)Device
Patients that are indicated for an ICD or CRT-D receive one of these devices.
| Study group | Role | What they receive |
|---|---|---|
| 2.5/3.5/4.5 ms defibrillation waveform | Experimental | Not described Receives: Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
Measured: Implant
DFT (2.5 ms Waveform)
Measured: Implant
DFT (4.5 ms Waveform)
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shephal Doshi, MD, Principal investigator, Pacific Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311181
- Sponsor's protocol ID
- CRD 324
- Status last verified
- Feb 2019
- First submitted
- 3 Apr 2006
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms
- ClinicalTrials.gov ID
- NCT00311181
- Acronym / sponsor ID
- CRD 324
- Conditions
- Sudden Cardiac Death
- Keywords
- ICD, Defibrillation, ULV, Tuned
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Posted 30 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2.5/3.5/4.5 ms defibrillation waveform | Experimental | Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patient has a mechanical valve in the tricuspid position.
- Patient has epicardial defibrillation electrodes.
- Patient is pregnant.
- Patient is less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)Patients that are indicated for an ICD or CRT-D receive one of these devices. | Device | 2.5/3.5/4.5 ms defibrillation waveform |
Primary outcome
Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
Time frame: Implant
DFT (2.5 ms Waveform)
Time frame: Implant
DFT (4.5 ms Waveform)
Time frame: Implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shephal Doshi, MD principal investigator
Pacific Heart Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D) in people with Sudden Cardiac Death, run by Abbott Medical Devices at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defibrillation Thresholds (DFTs) (3.5 ms Waveform) (time frame: Implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.