DFT TestingNCT01325922
50/50% Tilt and Tuned Defibrillation Waveform
A study testing DFT Testing with a 50/50% tilt in people with DFT Testing, run by Abbott Medical Devices.
Trial summary
Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DFT Testing
- What is being tested?
- DFT Testing with a 50/50% tilt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Patient is a candidate for ICD implantation.
- Patient is able to tolerate DFT testing.
Who cannot join
- Patient has a mechanical valve in the tricuspid position.
- Patient is pregnant.
- Patient is less than 18 years old.
About this study
Official title: 50/50% Tilt and Tune Defibrillation Waveforms Utilizing High Voltage Lead Integrity Check Impedance
Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance.
Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the 50/50% tilt waveform.
Read more
Study Methods
- This is an acute, paired-sample, randomized (waveform testing sequence) study
- Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other standard output ICD after Epic+) and defibrillation lead system.
- All study testing is completed at implant.
- Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned waveform.
- The HVLIC feature is used to measure the high voltage lead impedance and to program the Tuned and 50/50% tilt waveform pulse widths.
- The DFT is determined by an optimized binary search method that is designed to reduce the overall number of VF inductions to an average of 5.13 while maintaining very high resolution and accuracy.
- Total # of centers - 15 centers
- Sample size - 60 patients
- Conditions
- DFT Testing
- Being tested
- DFT Testing with a 50/50% tilt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFT Testing with a 50/50% tiltProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 50/50% Tilt | Other | Not described Receives: Procedure: DFT Testing with a 50/50% tilt |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJan 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DFT TestingStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325922
- Sponsor's protocol ID
- CRD 274
- Status last verified
- Feb 2019
- First submitted
- 16 May 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 50/50% Tilt and Tune Defibrillation Waveforms Utilizing High Voltage Lead Integrity Check Impedance
- ClinicalTrials.gov ID
- NCT01325922
- Acronym / sponsor ID
- CRD 274
- Conditions
- DFT Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance.
Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the 50/50% tilt waveform.
Study Methods
- This is an acute, paired-sample, randomized (waveform testing sequence) study
- Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other standard output ICD after Epic+) and defibrillation lead system.
- All study testing is completed at implant.
- Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned waveform.
- The HVLIC feature is used to measure the high voltage lead impedance and to program the Tuned and 50/50% tilt waveform pulse widths.
- The DFT is determined by an optimized binary search method that is designed to reduce the overall number of VF inductions to an average of 5.13 while maintaining very high resolution and accuracy.
- Total # of centers - 15 centers
- Sample size - 60 patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50/50% Tilt | Other | Procedure: DFT Testing with a 50/50% tilt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is a candidate for ICD implantation.
- Patient is able to tolerate DFT testing.
Key exclusion criteria (3 listed)
- Patient has a mechanical valve in the tricuspid position.
- 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 |
|---|---|---|
| DFT Testing with a 50/50% tilt | Procedure or surgery | 50/50% Tilt |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DFT Testing with a 50/50% tilt in people with DFT Testing, run by Abbott Medical Devices.
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 2 inclusion and 3 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Feb 2019.