Heart FailureNCT00798174
The Effect of an Azygos Vein Coil on Defibrillation Threshold
A study testing Standard configuration vs. azygos coil in people with Heart Failure, run by Washington University School of Medicine at 1 site in United States.
Trial summary
When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias is determined. The device is then programmed to discharge a larger amount of energy in order to provide a safety margin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Standard configuration vs. azygos coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2008to 18 Nov 2009
- Phase
- Interventional
- 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
- Any patient undergoing elective placement of an ICD for the primary or secondary prevention of sudden cardiac death is eligible. Exclusion criteria include any contraindication to endovascular ICD implantation which includes but is not limited to; active infection, occluded venous access, or inability to perform DFT testing secondary to the inability to sedate the patient or hemodynamic compromise.
Who cannot join
- Any contraindication to ICD or the inability to place an azygos vein coil.
Trial locations and contacts
1 site in 1 country.
About this study
When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias is determined. The device is then programmed to discharge a larger amount of energy in order to provide a safety margin. In some patients, the DFT is so high, that an adequate safety margin is not programmable. Placement of a defibrillation lead in the azygos vein has been found to be helpful in these patients. This goal of this trial is to attempt to quantify the average reduction in the DFT (if any) that results from the addition of the azygos lead.
Read the detailed description
Patients undergoing placement of an ICD for the primary or secondary prevention of sudden cardiac death will be asked to participate. Patients will undergo implantation of a standard right ventricular ICD lead at the time of ICD implantation. In addition, patient will receive another high voltage ICD lead placed in the azygos vein as has been previously described in the literature (1). After sedating the patient, the DFT will be determined using a binary search algorithm. This consists of testing the device at a given output for the first shock after inducing ventricular fibrillation (VF). Should the shock fail, external defibrillation will be attempted, as is the standard method for performing DFT testing. As per the standard method of DFT testing, VF will be induced a second time, with the shock strength dependent on the success of the first shock. If the first shock was unsuccessful, the second will be at a higher output. If the first shock was successful, the second will be at a lower output. A third shock will then be delivered, based on the success or failure of the preceding shock to define the DFT. Of note, as the device can be programmed to give multiple shocks for one episode, VF will not necessarily need to be induced each time. For example, VF could be induced, and the device programmed to give a 20 Joule (J) shock followed by a 23J shock if not successful, thus limiting the number of VF inductions required. DFT testing will be done using both the standard configuration of high voltage leads as well as using the azygos lead. We hypothesize that using the azygos lead will result in a lower DFT.
- Conditions
- Heart Failure
- Being tested
- Standard configuration vs. azygos coil
- Keywords
- DFT, Congestive Heart failure (CHF), ICD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard configuration vs. azygos coilDevice
Also called Medtronic 6937A Lead
Addition of an azygos vein defibrillation coil instead of a standard SVC coil.
| Study group | Role | What they receive |
|---|---|---|
| Standard configuration vs. azygos coil | Experimental | The DFT with the standard Superior Vena Cava (SVC) coil vs. DFT with the azygos coil.
In this crossover study, each patient serves and own control, with defibrillation testing performed with and with the azygos coil Receives: Device: Standard configuration vs. azygos coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil.
Defibrillation threshold will be estimated by repeat defibrillation testing using an azygos coil and using an SVC coil (and compared).
The outcome measure quoted below is the mean DFT using the azygos coil vs. the mean DFT using the standard configuration.
Measured: During the course of the implant procedure and testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study start15 Dec 2008
- Primary completion18 Nov 2009
- Study completion18 Nov 2009
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group undergoing crossover in therapy (defibrillation testing with two different device configurations).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Timothy W. Smith, DPhil, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798174
- Sponsor's protocol ID
- 08-0045
- Status last verified
- Aug 2018
- First submitted
- 24 Nov 2008
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cooper JA, Latacha MP, Soto GE, Garmany RG, Gleva MJ, Chen J, Faddis MN, Smith TW. The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series. Pacing Clin Electrophysiol. 2008 Nov;31(11):1405-10. doi: 10.1111/j.1540-8159.2008.01203.x.
PubMed 18950297Cesario D, Bhargava M, Valderrabano M, Fonarow GC, Wilkoff B, Shivkumar K. Azygos vein lead implantation: a novel adjunctive technique for implantable cardioverter defibrillator placement. J Cardiovasc Electrophysiol. 2004 Jul;15(7):780-3. doi: 10.1046/j.1540-8167.2004.03649.x.
PubMed 15250862
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Azygos Vein Coil on Defibrillation Threshold
- ClinicalTrials.gov ID
- NCT00798174
- Acronym / sponsor ID
- 08-0045
- Conditions
- Heart Failure
- Keywords
- DFT, Congestive Heart failure (CHF), ICD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Dec 2008 (actual)
- Primary completion
- 18 Nov 2009 (actual)
- Study completion
- 18 Nov 2009 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 28 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias is determined. The device is then programmed to discharge a larger amount of energy in order to provide a safety margin. In some patients, the DFT is so high, that an adequate safety margin is not programmable. Placement of a defibrillation lead in the azygos vein has been found to be helpful in these patients. This goal of this trial is to attempt to quantify the average reduction in the DFT (if any) that results from the addition of the azygos lead.
Detailed description
Patients undergoing placement of an ICD for the primary or secondary prevention of sudden cardiac death will be asked to participate. Patients will undergo implantation of a standard right ventricular ICD lead at the time of ICD implantation. In addition, patient will receive another high voltage ICD lead placed in the azygos vein as has been previously described in the literature (1). After sedating the patient, the DFT will be determined using a binary search algorithm. This consists of testing the device at a given output for the first shock after inducing ventricular fibrillation (VF). Should the shock fail, external defibrillation will be attempted, as is the standard method for performing DFT testing. As per the standard method of DFT testing, VF will be induced a second time, with the shock strength dependent on the success of the first shock. If the first shock was unsuccessful, the second will be at a higher output. If the first shock was successful, the second will be at a lower output. A third shock will then be delivered, based on the success or failure of the preceding shock to define the DFT. Of note, as the device can be programmed to give multiple shocks for one episode, VF will not necessarily need to be induced each time. For example, VF could be induced, and the device programmed to give a 20 Joule (J) shock followed by a 23J shock if not successful, thus limiting the number of VF inductions required. DFT testing will be done using both the standard configuration of high voltage leads as well as using the azygos lead. We hypothesize that using the azygos lead will result in a lower DFT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group undergoing crossover in therapy (defibrillation testing with two different device configurations).
| Arm | Type | Receives |
|---|---|---|
| Standard configuration vs. azygos coil | Experimental | Device: Standard configuration vs. azygos coilThe DFT with the standard Superior Vena Cava (SVC) coil vs. DFT with the azygos coil. In this crossover study, each patient serves and own control, with defibrillation testing performed with and with the azygos coil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing elective placement of an ICD for the primary or secondary prevention of sudden cardiac death is eligible. Exclusion criteria include any contraindication to endovascular ICD implantation which includes but is not limited to; active infection, occluded venous access, or inability to perform DFT testing secondary to the inability to sedate the patient or hemodynamic compromise.
Key exclusion criteria (1 listed)
- Any contraindication to ICD or the inability to place an azygos vein coil.
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 |
|---|---|---|
| Standard configuration vs. azygos coilAlso: Medtronic 6937A LeadAddition of an azygos vein defibrillation coil instead of a standard SVC coil. | Device | Standard configuration vs. azygos coil |
Primary outcome
Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil.
Time frame: During the course of the implant procedure and testing
Defibrillation threshold will be estimated by repeat defibrillation testing using an azygos coil and using an SVC coil (and compared). The outcome measure quoted below is the mean DFT using the azygos coil vs. the mean DFT using the standard configuration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18950297Cooper JA, Latacha MP, Soto GE, Garmany RG, Gleva MJ, Chen J, Faddis MN, Smith TW. The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series. Pacing Clin Electrophysiol. 2008 Nov;31(11):1405-10. doi: 10.1111/j.1540-8159.2008.01203.x.
- Background: PubMed 15250862Cesario D, Bhargava M, Valderrabano M, Fonarow GC, Wilkoff B, Shivkumar K. Azygos vein lead implantation: a novel adjunctive technique for implantable cardioverter defibrillator placement. J Cardiovasc Electrophysiol. 2004 Jul;15(7):780-3. doi: 10.1046/j.1540-8167.2004.03649.x.
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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.
Timothy W. Smith, DPhil, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard configuration vs. azygos coil in people with Heart Failure, run by Washington University School of Medicine 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 1 inclusion and 1 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 28 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2018). 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?
Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. (time frame: During the course of the implant procedure and testing). 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 NCT00798174, which also lists 2 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 28 Sep 2018.