HealthyTilt & TuneNCT00873691
Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants
An observational study of Healthy, 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 patients with right-sided implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ICD
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Nov 2011
- 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 approved ICD/CRT-D indications
Who may be able to join
- Patient meets standard indication for an ICD/ CRT-D
- Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
- Pulse generator will be implanted on the right-side
- Patient is able to tolerate DFT testing.
- RV lead will be placed in the RV apex or inferior septum
Who cannot join
- 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 Right-Sided Implants
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.
Read the detailed description
Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog has primarily centered around left sided implants, a group that is characterized by a small incidence of high defibrillation thresholds (DFTs).
The mechanism of phase duration programming to improve DFTs would seem to be most effectively applied to a group of patients with a high incidence of high DFTs such as right sided implants. This study therefore aims to prospectively evaluate direct phase duration programming on DFTs in right sided implants.
- Conditions
- Healthy
- Being tested
- ICD
- Keywords
- Patients indicated for an ICD/ CRT-D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
Intervention isn an ICD. 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 |
|---|---|---|
| 1 | ICD shocks programmed to Tuned Waveform Receives: Device: ICD | |
| 2 | ICD shocks programmed to 50% Tilt waveform Receives: Device: ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)
Measured: Baseline
Secondary outcomes (1)
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niraj Varma, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873691
- Sponsor's protocol ID
- CRD 442
- Acronym
- Tilt & Tune
- Status last verified
- Feb 2019
- First submitted
- 30 Mar 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Varma N, Efimov I. Right pectoral implantable cardioverter defibrillators: role of the proximal (SVC) coil. Pacing Clin Electrophysiol. 2008 Aug;31(8):1025-35. doi: 10.1111/j.1540-8159.2008.01130.x.
PubMed 18684259Natarajan 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 17302691Varma N, Schaerf R, Kalbfleisch S, Pimentel R, Kroll MW, Oza A. Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial). Europace. 2017 Nov 1;19(11):1810-1817. doi: 10.1093/europace/euw306.
PubMed 27986795
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 Right-Sided Implants
- ClinicalTrials.gov ID
- NCT00873691
- Acronym / sponsor ID
- Tilt & Tune / CRD 442
- Conditions
- Healthy
- Keywords
- Patients indicated for an ICD/ CRT-D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 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 patients with right-sided implants.
Detailed description
Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog has primarily centered around left sided implants, a group that is characterized by a small incidence of high defibrillation thresholds (DFTs).
The mechanism of phase duration programming to improve DFTs would seem to be most effectively applied to a group of patients with a high incidence of high DFTs such as right sided implants. This study therefore aims to prospectively evaluate direct phase duration programming on DFTs in right sided implants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: ICDICD shocks programmed to Tuned Waveform |
| 2 | – | Device: ICDICD shocks programmed to 50% Tilt waveform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with approved ICD/CRT-D indications
Key inclusion criteria (5 listed)
- Patient meets standard indication for an ICD/ CRT-D
- Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
- Pulse generator will be implanted on the right-side
- Patient is able to tolerate DFT testing.
- RV lead will be placed in the RV apex or inferior septum
Key exclusion criteria (3 listed)
- 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 |
|---|---|---|
| ICDIntervention isn an ICD. 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. | Device | 1, 2 |
Primary outcome
True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)
Time frame: Baseline
1 secondary outcome
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)
Time frame: Baseline
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 18684259Varma N, Efimov I. Right pectoral implantable cardioverter defibrillators: role of the proximal (SVC) coil. Pacing Clin Electrophysiol. 2008 Aug;31(8):1025-35. doi: 10.1111/j.1540-8159.2008.01130.x.
- 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.
- Derived from this study: PubMed 27986795Varma N, Schaerf R, Kalbfleisch S, Pimentel R, Kroll MW, Oza A. Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial). Europace. 2017 Nov 1;19(11):1810-1817. doi: 10.1093/europace/euw306.
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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.
Niraj Varma, MD principal investigator
The Cleveland Clinic
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 Healthy, 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 5 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.
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 Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V) (time frame: Baseline). 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 NCT00873691, which also lists 3 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.