Ventricular ArrhythmiasPhase 4TNT-ICDNCT01905007
Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation
A Phase 4 study testing Defibrillation testing in people with Ventricular Arrhythmias, run by The Cooper Health System at 2 sites in United States.
Trial summary
The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias
- What is being tested?
- Defibrillation testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Dec 2014
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II indication according to the ACC/AHA/HRS practice guidelines
- Anticipated life expectancy >6 months
Who cannot join
- Contraindications to defibrillation testing as determined by the managing physician*
- ICD replacement implants
- Right-sided pectoral implants
- Abdominal implants
- Chronic oral amiodarone therapy (for >6 weeks and continued need for amiodarone)
- Inability to give informed consent
- Contraindications to defibrillation testing include the following: hemodynamic instability, LA thrombus, atrial fibrillation without adequate anticoagulation, LV thrombus, recent CVA or TIA, severe unrevascularized coronary artery disease or unstable angina, severe aortic stenosis, inotropic dependence, patient refusal, other patient-specific medical conditions that are deemed as contraindications, as determined by the implanting physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Andrea M. Russo, M.D., 856-968-7096
Julie Field, 856-669-8847, Field-Julie@cooperhealth.edu
- Not yet recruiting
University of Washington
Seattle, Washington, 98195
Jeanne Poole, MD
Jeanne Poole, MD
About this study
Official title: "Test-No Test" Implantable Cardioverter Defibrillator Pilot Study (TNT-ICD)
The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation.
Read the detailed description
Implantable cardioverter-defibrillators (ICDs) are the most effective treatment for the primary and secondary prevention of sudden cardiac death (SCD). At the time of ICD implantation, ventricular fibrillation (VF) is typically induced to demonstrate effective arrhythmia termination by the implanted device. Although defibrillation threshold (DFT) testing with induction of VF at time of ICD insertion is currently considered the "standard of care," and instructions for usage of devices approved by the Food and Drug Administration (FDA) include labeling with DFT testing, the value of defibrillation testing with modern-day devices has been questioned. Defibrillation testing can be associated with serious complications and may add to the cost of the procedure.
It is hypothesized that patients who do not undergo defibrillation testing will have outcomes similar to those who do undergo defibrillation testing at the time of initial implantation. This pilot study is being performed to determine the feasibility of performing a larger, multi-center clinical trial with longer follow-up to investigate whether or not defibrillation testing will have any impact on overall mortality, implant complications, or long-term first shock efficacy during clinical follow-up.
- Conditions
- Ventricular Arrhythmias
- Being tested
- Defibrillation testing
- Keywords
- Implantable cardioverter defibrillator, Defibrillation threshold testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillation testingDevice
Also called Medtronic implantable cardioverter defibrillator
Defibrillation testing at initial ICD implantation
| Study group | Role | What they receive |
|---|---|---|
| Defibrillation testing | Active comparator | Defibrillation testing at initial ICD implantation Receives: Device: Defibrillation testing |
| No defibrillation testing | No intervention | No defibrillation testing at initial ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite all-cause mortality and operative complications
The composite endpoint of implant complications and mortality rates will be compared in the DFT vs. no DFT groups.
Measured: Procedure-related complications will be defined as those occurring within 90 days post-implantation and mortality will be measured at 2 year follow-up
Secondary outcomes (1)
1st shock efficacy for clinical occurrence of ventricular tachycardia (VT)/VF
The efficacy of 1st shock therapy for VT/VF will be compared between the DFT and no DFT groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, University of Washington
- Responsible party
- Principal investigator, Andrea M. Russo, MD, The Cooper Health System
- Investigators
- Andrea M. Russo, MD, Principal investigator, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905007
- Sponsor's protocol ID
- CUH-09-087
- Acronym
- TNT-ICD
- Status last verified
- Jul 2013
- First submitted
- 24 Feb 2012
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Russo AM, Sauer W, Gerstenfeld EP, Hsia HH, Lin D, Cooper JM, Dixit S, Verdino RJ, Nayak HM, Callans DJ, Patel V, Marchlinski FE. Defibrillation threshold testing: is it really necessary at the time of implantable cardioverter-defibrillator insertion? Heart Rhythm. 2005 May;2(5):456-61. doi: 10.1016/j.hrthm.2005.01.015.
PubMed 15840466Swerdlow CD, Russo AM, Degroot PJ. The dilemma of ICD implant testing. Pacing Clin Electrophysiol. 2007 May;30(5):675-700. doi: 10.1111/j.1540-8159.2007.00730.x.
PubMed 17461879Mainigi SK, Cooper JM, Russo AM, Nayak HM, Lin D, Dixit S, Gerstenfeld EP, Hsia HH, Callans DJ, Marchlinski FE, Verdino RJ. Elevated defibrillation thresholds in patients undergoing biventricular defibrillator implantation: incidence and predictors. Heart Rhythm. 2006 Sep;3(9):1010-6. doi: 10.1016/j.hrthm.2006.05.028. Epub 2006 Jun 15.
PubMed 16945792Blatt JA, Poole JE, Johnson GW, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Anderson J, Chung K, Wong WS, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators. No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2008 Aug 12;52(7):551-6. doi: 10.1016/j.jacc.2008.04.051.
PubMed 18687249Birnie D, Tung S, Simpson C, Crystal E, Exner D, Ayala Paredes FA, Krahn A, Parkash R, Khaykin Y, Philippon F, Guerra P, Kimber S, Cameron D, Healey JS. Complications associated with defibrillation threshold testing: the Canadian experience. Heart Rhythm. 2008 Mar;5(3):387-90. doi: 10.1016/j.hrthm.2007.11.018. Epub 2007 Nov 28.
PubMed 18243813Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol. 2006 Feb;17(2):140-5. doi: 10.1111/j.1540-8167.2005.00294.x.
PubMed 16533250
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Test-No Test" Implantable Cardioverter Defibrillator Pilot Study (TNT-ICD)
- ClinicalTrials.gov ID
- NCT01905007
- Acronym / sponsor ID
- TNT-ICD / CUH-09-087
- Conditions
- Ventricular Arrhythmias
- Keywords
- Implantable cardioverter defibrillator, Defibrillation threshold testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Collaborators
- Medtronic, University of Washington
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Jul 2013 (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 primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation.
Detailed description
Implantable cardioverter-defibrillators (ICDs) are the most effective treatment for the primary and secondary prevention of sudden cardiac death (SCD). At the time of ICD implantation, ventricular fibrillation (VF) is typically induced to demonstrate effective arrhythmia termination by the implanted device. Although defibrillation threshold (DFT) testing with induction of VF at time of ICD insertion is currently considered the "standard of care," and instructions for usage of devices approved by the Food and Drug Administration (FDA) include labeling with DFT testing, the value of defibrillation testing with modern-day devices has been questioned. Defibrillation testing can be associated with serious complications and may add to the cost of the procedure.
It is hypothesized that patients who do not undergo defibrillation testing will have outcomes similar to those who do undergo defibrillation testing at the time of initial implantation. This pilot study is being performed to determine the feasibility of performing a larger, multi-center clinical trial with longer follow-up to investigate whether or not defibrillation testing will have any impact on overall mortality, implant complications, or long-term first shock efficacy during clinical follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defibrillation testing | Active comparator | Device: Defibrillation testingDefibrillation testing at initial ICD implantation |
| No defibrillation testing | No intervention | –No defibrillation testing at initial ICD implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II indication according to the ACC/AHA/HRS practice guidelines
- Anticipated life expectancy >6 months
Key exclusion criteria (7 listed)
- Contraindications to defibrillation testing as determined by the managing physician*
- ICD replacement implants
- Right-sided pectoral implants
- Abdominal implants
- Chronic oral amiodarone therapy (for >6 weeks and continued need for amiodarone)
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 |
|---|---|---|
| Defibrillation testingAlso: Medtronic implantable cardioverter defibrillatorDefibrillation testing at initial ICD implantation | Device | Defibrillation testing |
Primary outcome
Composite all-cause mortality and operative complications
Time frame: Procedure-related complications will be defined as those occurring within 90 days post-implantation and mortality will be measured at 2 year follow-up
The composite endpoint of implant complications and mortality rates will be compared in the DFT vs. no DFT groups.
1 secondary outcome
1st shock efficacy for clinical occurrence of ventricular tachycardia (VT)/VF
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Background: PubMed 15840466Russo AM, Sauer W, Gerstenfeld EP, Hsia HH, Lin D, Cooper JM, Dixit S, Verdino RJ, Nayak HM, Callans DJ, Patel V, Marchlinski FE. Defibrillation threshold testing: is it really necessary at the time of implantable cardioverter-defibrillator insertion? Heart Rhythm. 2005 May;2(5):456-61. doi: 10.1016/j.hrthm.2005.01.015.
- Background: PubMed 17461879Swerdlow CD, Russo AM, Degroot PJ. The dilemma of ICD implant testing. Pacing Clin Electrophysiol. 2007 May;30(5):675-700. doi: 10.1111/j.1540-8159.2007.00730.x.
- Background: PubMed 16945792Mainigi SK, Cooper JM, Russo AM, Nayak HM, Lin D, Dixit S, Gerstenfeld EP, Hsia HH, Callans DJ, Marchlinski FE, Verdino RJ. Elevated defibrillation thresholds in patients undergoing biventricular defibrillator implantation: incidence and predictors. Heart Rhythm. 2006 Sep;3(9):1010-6. doi: 10.1016/j.hrthm.2006.05.028. Epub 2006 Jun 15.
- Background: PubMed 18687249Blatt JA, Poole JE, Johnson GW, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Anderson J, Chung K, Wong WS, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators. No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2008 Aug 12;52(7):551-6. doi: 10.1016/j.jacc.2008.04.051.
- Background: PubMed 18243813Birnie D, Tung S, Simpson C, Crystal E, Exner D, Ayala Paredes FA, Krahn A, Parkash R, Khaykin Y, Philippon F, Guerra P, Kimber S, Cameron D, Healey JS. Complications associated with defibrillation threshold testing: the Canadian experience. Heart Rhythm. 2008 Mar;5(3):387-90. doi: 10.1016/j.hrthm.2007.11.018. Epub 2007 Nov 28.
- Background: PubMed 16533250Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol. 2006 Feb;17(2):140-5. doi: 10.1111/j.1540-8167.2005.00294.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.
Andrea M. Russo, MD principal investigator
The Cooper Health System
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 Defibrillation testing in people with Ventricular Arrhythmias, run by The Cooper Health System 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jul 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea M. Russo, MD (856-968-7096, russo-andrea@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite all-cause mortality and operative complications (time frame: Procedure-related complications will be defined as those occurring within 90 days post-implantation and mortality will be measured at 2 year follow-up). 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 NCT01905007, which also lists 6 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 22 Jul 2013.