Sudden Cardiac DeathPROMISENCT00874445
Comparison of 50% Tilt and Tuned Waveforms in Single-Coil Active Can Configuration
An observational study of Sudden Cardiac Death, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- ICD/ CRT-D
- Type of treatment
- Medical device
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2010
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ICD/CRT-D indications
Who may be able to join
- Patient meets standard indication for an ICD/ CRT-D and will be implanted with an FDA approved SJM ICD/ CRT-D and compatible defibrillation lead system in the left pectoral region.
- Patient is able to tolerate DFT testing.
Who cannot join
- Patient has the pulse generator on the right side.
- Patient is pregnant.
- Patient is less than 18 years old.
- SVC coil was turned ON during DFT testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in a Single Coil Active Can Configuration
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.
Read the detailed description
There has been one prospective study that found some benefit of using tuned waveforms over 50/50% tilt waveforms.11 Other studies have failed to show much change in defibrillation efficacy with different duration biphasic waveforms. A vast majority of patients in these studies were tested with dual coil leads. Although dual coil leads can lower defibrillation thresholds, it is known that dual coil leads can make the lead extraction difficult, lead to venous obstruction and are more prone to failure. Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms. This makes the use of single-coil leads during ICD/ CRT-D implants an attractive option.
Theoretical analysis has shown that difference between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished). Accordingly, this study has been designed to prospectively compare the DFT estimates with tuned and 50% tilt waveforms in left-sided, active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit.
- Conditions
- Sudden Cardiac Death
- Being tested
- ICD/ CRT-D
- 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.
ICD/ CRT-DDevice
Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.
| Study group | Role | What they receive |
|---|---|---|
| ICD shocks programmed to Tuned Waveform | ICD shocks programmed to Tuned Waveform Receives: Device: ICD/ CRT-D | |
| ICD shocks programmed to Fixed Tilt Waveform | ICD shocks programmed to Fixed Tilt Waveform Receives: Device: ICD/ CRT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
True DFTs in fixed tilt and tuned waveforms obtained in volts (V)
Measured: Implant
Secondary outcomes (1)
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Gold, MD, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874445
- Sponsor's protocol ID
- CRD 475
- Acronym
- PROMISE
- Status last verified
- Feb 2019
- First submitted
- 31 Mar 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gold M, Val-Mejias J, Leman RB, Tummala R, Goyal S, Kluger J, Kroll M, Oza A. Optimization of superior vena cava coil position and usage for transvenous defibrillation. Heart Rhythm. 2008 Mar;5(3):394-9. doi: 10.1016/j.hrthm.2007.12.001. Epub 2007 Dec 5.
PubMed 18313597Natarajan S, Henthorn R, Burroughs J, Esberg D, Zweibel S, Ross T, Kroll M, Gianola D, Oza A. "Tuned" defibrillation waveforms outperform 50/50% tilt defibrillation waveforms: a randomized multi-center study. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S139-42. doi: 10.1111/j.1540-8159.2007.00624.x.
PubMed 17302691Mouchawar G, Kroll M, Val-Mejias JE, Schwartzman D, McKenzie J, Fitzgerald D, Prater S, Katcher M, Fain E, Syed Z. ICD waveform optimization: a randomized, prospective, pair-sampled multicenter study. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1992-5. doi: 10.1111/j.1540-8159.2000.tb07070.x.
PubMed 11139975Gold MR, Val-Mejias J, Cuoco F, Siddiqui M. Comparison of fixed tilt and tuned defibrillation waveforms: the PROMISE study. J Cardiovasc Electrophysiol. 2013 Mar;24(3):323-7. doi: 10.1111/jce.12041. Epub 2012 Dec 4.
PubMed 23210764Gold MR, Yu Y, Singh JP, Birgersdotter-Green U, Stein KM, Wold N, Meyer TE, Ellenbogen KA. Effect of Interventricular Electrical Delay on Atrioventricular Optimization for Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2018 Aug;11(8):e006055. doi: 10.1161/CIRCEP.117.006055.
PubMed 30354310
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
- Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in a Single Coil Active Can Configuration
- ClinicalTrials.gov ID
- NCT00874445
- Acronym / sponsor ID
- PROMISE / CRD 475
- Conditions
- Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Apr 2009 (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.
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.
Detailed description
There has been one prospective study that found some benefit of using tuned waveforms over 50/50% tilt waveforms.11 Other studies have failed to show much change in defibrillation efficacy with different duration biphasic waveforms. A vast majority of patients in these studies were tested with dual coil leads. Although dual coil leads can lower defibrillation thresholds, it is known that dual coil leads can make the lead extraction difficult, lead to venous obstruction and are more prone to failure. Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms. This makes the use of single-coil leads during ICD/ CRT-D implants an attractive option.
Theoretical analysis has shown that difference between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished). Accordingly, this study has been designed to prospectively compare the DFT estimates with tuned and 50% tilt waveforms in left-sided, active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD shocks programmed to Tuned Waveform | – | Device: ICD/ CRT-DICD shocks programmed to Tuned Waveform |
| ICD shocks programmed to Fixed Tilt Waveform | – | Device: ICD/ CRT-DICD shocks programmed to Fixed Tilt Waveform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ICD/CRT-D indications
Key inclusion criteria (2 listed)
- Patient meets standard indication for an ICD/ CRT-D and will be implanted with an FDA approved SJM ICD/ CRT-D and compatible defibrillation lead system in the left pectoral region.
- Patient is able to tolerate DFT testing.
Key exclusion criteria (4 listed)
- Patient has the pulse generator on the right side.
- Patient is pregnant.
- Patient is less than 18 years old.
- SVC coil was turned ON during DFT testing
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 |
|---|---|---|
| ICD/ CRT-DPatients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform. | Device | ICD shocks programmed to Fixed Tilt Waveform, ICD shocks programmed to Tuned Waveform |
Primary outcome
True DFTs in fixed tilt and tuned waveforms obtained in volts (V)
Time frame: Implant
1 secondary outcome
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)
Time frame: Implant
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.
- Background: PubMed 18313597Gold M, Val-Mejias J, Leman RB, Tummala R, Goyal S, Kluger J, Kroll M, Oza A. Optimization of superior vena cava coil position and usage for transvenous defibrillation. Heart Rhythm. 2008 Mar;5(3):394-9. doi: 10.1016/j.hrthm.2007.12.001. Epub 2007 Dec 5.
- Background: PubMed 17302691Natarajan S, Henthorn R, Burroughs J, Esberg D, Zweibel S, Ross T, Kroll M, Gianola D, Oza A. "Tuned" defibrillation waveforms outperform 50/50% tilt defibrillation waveforms: a randomized multi-center study. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S139-42. doi: 10.1111/j.1540-8159.2007.00624.x.
- Background: PubMed 11139975Mouchawar G, Kroll M, Val-Mejias JE, Schwartzman D, McKenzie J, Fitzgerald D, Prater S, Katcher M, Fain E, Syed Z. ICD waveform optimization: a randomized, prospective, pair-sampled multicenter study. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1992-5. doi: 10.1111/j.1540-8159.2000.tb07070.x.
- Results publication: PubMed 23210764Gold MR, Val-Mejias J, Cuoco F, Siddiqui M. Comparison of fixed tilt and tuned defibrillation waveforms: the PROMISE study. J Cardiovasc Electrophysiol. 2013 Mar;24(3):323-7. doi: 10.1111/jce.12041. Epub 2012 Dec 4.
- Derived from this study: PubMed 30354310Gold MR, Yu Y, Singh JP, Birgersdotter-Green U, Stein KM, Wold N, Meyer TE, Ellenbogen KA. Effect of Interventricular Electrical Delay on Atrioventricular Optimization for Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2018 Aug;11(8):e006055. doi: 10.1161/CIRCEP.117.006055.
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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.
Michael Gold, MD, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Abbott Medical Devices at 1 site 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 2 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 4 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 1 site 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.
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.
What does the primary outcome measure?
True DFTs in fixed tilt and tuned waveforms obtained in volts (V) (time frame: Implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00874445, which also lists 5 linked publications.
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.