CardiomyopathyULVNCT02111993
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
A study testing Standard Defibrillation Testing and Upper Limit of Vulnerability Testing in people with Cardiomyopathy and Heart Failure, run by University of California, San Diego at 1 site in United States.
Trial summary
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV) method vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- What is being tested?
- Standard Defibrillation Testing and Upper Limit of Vulnerability Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2015
- 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
- Patients eligible to receive an ICD implant or change out.
- Patients with a single or dual coil right ventricle (RV) defibrillation lead located in the RV apex.
- Patients greater than 18 years of age.
- Patients willing and able to give informed consent.
- Patients who have insurance which may cover additional hospital stay if myocardial injury resulted from testing
Who cannot join
- Patients with medical conditions that would limit study participation.
- Patients that are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Sulpizio Cardiovascular Center
La Jolla, California, 92093
About this study
Official title: Evaluating Myocardial Injury During ICD Implantation Using the Upper Limit of Vulnerability (ULV) Method vs. Standard Defibrillation Threshold Testing
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV) method vs. standard defibrillation threshold method.
Read the detailed description
This is a prospective, randomized (1:1 DFT vs ULV testing), controlled clinical research trial. Patients undergoing ICD implant or device change out will be candidates for this study. Medical records for these patients will be screened prior to enrollment to ensure eligibility for the study. Each patient who is a candidate and who agrees to participate in the study will undergo the standard of care pre-procedure evaluation including a complete medical history evaluation, a complete physical examination and routine laboratory testing including chemistry panel, hematology panel, coagulation panel, a 12-lead electrocardiogram, and a urine pregnancy test (all females of child-bearing age). A candidate patient will be randomly assigned to either the standard DFT testing method group or the ULV testing method group.
For the standard DFT testing group, per routine standard of care, the patient will be admitted to the hospital. The study requires a pre-procedure blood test of 3 ml for Troponin-T (TnT) which will be drawn prior to any DFT testing. The blood sample will be sent to the University of California, San Diego (UCSD) central laboratory for processing. The patient will then undergo the scheduled ICD implant procedure in a standard fashion. The standard defibrillation threshold testing will be performed using a low energy shock delivered on T-wave to induce ventricular fibrillation (VF). If VF is induced, the first shock is 25 Joules (J). If success, we will wait 5 minutes and repeat the process. If the 2nd shock yields success, the DFT testing is complete and a 10J safety margin achieved (device shock energy is set at 35J or as clinically indicated determined by treating Cardiac Electrophysiologist). A back-up external defibrillator will always be immediately available in case transvenous shocks fail. Blood pressure will be monitored before and immediately after each shock. After 4 hours, 8 hours and 16 hours post DFT testing, blood samples (3 ml for Troponin-T) will be drawn and sent to the UCSD central laboratory for processing.
For the ULV testing group, per routine standard of care, the patient will be admitted to the hospital. The study requires a pre-procedure blood test (3 ml for Troponin-T.) which will be drawn prior to any ULV testing. The blood sample will be sent to the UCSD central laboratory for processing. The patient will then undergo the scheduled ICD implant procedure as is standard clinical care. The ULV testing is performed as follows: for single coil device, a 18J shock will be delivered at 0msec, +20 msec, -20msec and -40msec measured from the peak of the T-wave; for dual coil device, a 18J shock will be delivered at 0msec, -20msec, +20msec, and +40msec measured from the peak of the T-wave. If VF is not induced with any of the above mentioned shocks, the ULV will be considered as 18J and the ICD will be implanted with the first shock strength set at 30 joules or as clinically indicated determined by treating Cardiac Electrophysiologist. If VF is induced, a 25J rescue shock will be delivered as is standard and if successful, the device will be programmed to the maximum output of 35 joules or as clinically indicated determined by treating Cardiac Electrophysiologist. Blood pressure will be monitored before and immediately after each shock. After 4 hours, 8 hours and 16 hours post ULV testing, blood samples (3 ml for Troponin-T) will be drawn and sent to the UCSD central laboratory for processing.
Other than the blood tests for Troponin-T, there is no change in routine post-operative management. Patients will be followed every three months, as is standard management for patients with ICDs.
The TnT blood draws at 4-hour, 8-hour and 16-hour post implantation will not require longer hospital stay than is standard for patients undergoing ICD implantation. The results of Troponin-T measurement for the study patients will be reviewed by the cardiac electrophysiology (EP) research staff. If myocardial injury is noted (any TnT value >0.1 as per current assay at the UCSD laboratory), the patient will be monitored as is deemed clinically necessary by treating Cardiac Electrophysiologist, including possible repeat TnT measurements for evaluation of myocardial infarction. We will follow standard of care for management of myocardial injury as recommended by the American Heart Association and the American College of Cardiology. Elevated TnT measurements may delay hospitalization, if determined to be clinically necessary. If the repeat TnT measurement is <0.1, then myocardial injury is most unlikely and the positive TnT value is likely due to DFT shocks.
- Conditions
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- Being tested
- Standard Defibrillation Testing, Upper Limit of Vulnerability Testing
- Keywords
- Defibrillation testing, Upper Limit of Vulnerability, ULV, DFT, ICD, implantable cardioverter defibrillator, cardiomyopathy, cardiac arrhythmia, cardiac device testing
- Medical subject headings
- Cardiomyopathies, Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Defibrillation TestingDevice
Also called ICD implantation
Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
Upper Limit of Vulnerability TestingDevice
Also called ICD implantation
Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Standard Defibrillation Testing | Active comparator | Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes. Receives: Device: Standard Defibrillation Testing |
| Upper Limit of VulnerabilityTesting | Active comparator | Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered. Receives: Device: Upper Limit of Vulnerability Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Damage
Myocardial damage will be evaluated by cardiac troponin (cTNT) lab collection before and then after ULV or DFT testing at 4 hours, 8 hours, and 20 hours.
Measured: 20 hours (hr)
Secondary outcomes (2)
Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)
the DFT group cardiac troponin (cTNT) values were compared to the subjects within the ULV group that required VF induction.
Measured: 20 hours (hr)
Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)
The DFT group was compared to the ULV subgroup that did not require ventricular fibrillation (VF) induction. Cardiac troponin (cTNT) levels were analyzed.
Measured: 20 hours (hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startAug 2011
- Primary completionApr 2015
- Study completionJun 2015
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 (13)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Ulrika Birgersdotter-Green, University of California, San Diego
- Investigators
- Ulrika Birgersdotter-Green, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111993
- Sponsor's protocol ID
- 110647
- Acronym
- ULV
- Status last verified
- May 2019
- First submitted
- 9 Apr 2014
- Last updated
- 22 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Swerdlow CD, Shehata M, Chen PS. Using the upper limit of vulnerability to assess defibrillation efficacy at implantation of ICDs. Pacing Clin Electrophysiol. 2007 Feb;30(2):258-70. doi: 10.1111/j.1540-8159.2007.00659.x.
PubMed 17338725Day JD, Doshi RN, Belott P, Birgersdotter-Green U, Behboodikhah M, Ott P, Glatter KA, Tobias S, Frumin H, Lee BK, Merillat J, Wiener I, Wang S, Grogin H, Chun S, Patrawalla R, Crandall B, Osborn JS, Weiss JP, Lappe DL, Neuman S. Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations). Circulation. 2007 May 8;115(18):2382-9. doi: 10.1161/CIRCULATIONAHA.106.663112. Epub 2007 Apr 30.
PubMed 17470697Chen PS, Shibata N, Dixon EG, Martin RO, Ideker RE. Comparison of the defibrillation threshold and the upper limit of ventricular vulnerability. Circulation. 1986 May;73(5):1022-8. doi: 10.1161/01.cir.73.5.1022.
PubMed 3698224Chen PS, Feld GK, Kriett JM, Mower MM, Tarazi RY, Fleck RP, Swerdlow CD, Gang ES, Kass RM. Relation between upper limit of vulnerability and defibrillation threshold in humans. Circulation. 1993 Jul;88(1):186-92. doi: 10.1161/01.cir.88.1.186.
PubMed 8319332Hwang C, Swerdlow CD, Kass RM, Gang ES, Mandel WJ, Peter CT, Chen PS. Upper limit of vulnerability reliably predicts the defibrillation threshold in humans. Circulation. 1994 Nov;90(5):2308-14. doi: 10.1161/01.cir.90.5.2308.
PubMed 7955188Martin DJ, Chen PS, Hwang C, Gang ES, Mandel WJ, Peter CT, Swerdlow CD. Upper limit of vulnerability predicts chronic defibrillation threshold for transvenous implantable defibrillators. J Cardiovasc Electrophysiol. 1997 Mar;8(3):241-8. doi: 10.1111/j.1540-8167.1997.tb00786.x.
PubMed 9083873Birgersdotter-Green U, Undesser K, Fujimura O, Feld GK, Kass RM, Mandel WJ, Peter CT, Chen PS. Correlation of acute and chronic defibrillation threshold with upper limit of vulnerability determined in normal sinus rhythm. J Interv Card Electrophysiol. 1999 Jul;3(2):155-61. doi: 10.1023/a:1009825731592.
PubMed 10387143Swerdlow CD, Davie S, Ahern T, Chen PS. Comparative reproducibility of defibrillation threshold and upper limit of vulnerability. Pacing Clin Electrophysiol. 1996 Dec;19(12 Pt 1):2103-11. doi: 10.1111/j.1540-8159.1996.tb03285.x.
PubMed 8994950Swerdlow CD, Ahern T, Kass RM, Davie S, Mandel WJ, Chen PS. Upper limit of vulnerability is a good estimator of shock strength associated with 90% probability of successful defibrillation in humans with transvenous implantable cardioverter-defibrillators. J Am Coll Cardiol. 1996 Apr;27(5):1112-8. doi: 10.1016/0735-1097(95)00603-6.
PubMed 8609329Swerdlow CD. Implantation of cardioverter defibrillators without induction of ventricular fibrillation. Circulation. 2001 May 1;103(17):2159-64. doi: 10.1161/01.cir.103.17.2159.
PubMed 11331256Green UB, Garg A, Al-Kandari F, Ungab G, Tone L, Feld GK. Successful implantation of cardiac defibrillators without induction of ventricular fibrillation using upper limit of vulnerability testing. J Interv Card Electrophysiol. 2003 Feb;8(1):71-5. doi: 10.1023/a:1022304417889.
PubMed 12652181Swerdlow C, Shivkumar K, Zhang J. Determination of the upper limit of vulnerability using implantable cardioverter-defibrillator electrograms. Circulation. 2003 Jun 24;107(24):3028-33. doi: 10.1161/01.CIR.0000074220.19414.18. Epub 2003 Jun 16.
PubMed 12810611Shehata M, Belk P, Kremers M, Saba S, Cao J, Swerdlow CD. Automatic determination of timing intervals for upper limit of vulnerability using ICD electrograms. Pacing Clin Electrophysiol. 2008 Jun;31(6):691-700. doi: 10.1111/j.1540-8159.2008.01072.x.
PubMed 18507541
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Myocardial Injury During ICD Implantation Using the Upper Limit of Vulnerability (ULV) Method vs. Standard Defibrillation Threshold Testing
- ClinicalTrials.gov ID
- NCT02111993
- Acronym / sponsor ID
- ULV / 110647
- Conditions
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- Keywords
- Defibrillation testing, Upper Limit of Vulnerability, ULV, DFT, ICD, implantable cardioverter defibrillator, cardiomyopathy, cardiac arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Aug 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Posted 22 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV) method vs. standard defibrillation threshold method.
Detailed description
This is a prospective, randomized (1:1 DFT vs ULV testing), controlled clinical research trial. Patients undergoing ICD implant or device change out will be candidates for this study. Medical records for these patients will be screened prior to enrollment to ensure eligibility for the study. Each patient who is a candidate and who agrees to participate in the study will undergo the standard of care pre-procedure evaluation including a complete medical history evaluation, a complete physical examination and routine laboratory testing including chemistry panel, hematology panel, coagulation panel, a 12-lead electrocardiogram, and a urine pregnancy test (all females of child-bearing age). A candidate patient will be randomly assigned to either the standard DFT testing method group or the ULV testing method group.
For the standard DFT testing group, per routine standard of care, the patient will be admitted to the hospital. The study requires a pre-procedure blood test of 3 ml for Troponin-T (TnT) which will be drawn prior to any DFT testing. The blood sample will be sent to the University of California, San Diego (UCSD) central laboratory for processing. The patient will then undergo the scheduled ICD implant procedure in a standard fashion. The standard defibrillation threshold testing will be performed using a low energy shock delivered on T-wave to induce ventricular fibrillation (VF). If VF is induced, the first shock is 25 Joules (J). If success, we will wait 5 minutes and repeat the process. If the 2nd shock yields success, the DFT testing is complete and a 10J safety margin achieved (device shock energy is set at 35J or as clinically indicated determined by treating Cardiac Electrophysiologist). A back-up external defibrillator will always be immediately available in case transvenous shocks fail. Blood pressure will be monitored before and immediately after each shock. After 4 hours, 8 hours and 16 hours post DFT testing, blood samples (3 ml for Troponin-T) will be drawn and sent to the UCSD central laboratory for processing.
For the ULV testing group, per routine standard of care, the patient will be admitted to the hospital. The study requires a pre-procedure blood test (3 ml for Troponin-T.) which will be drawn prior to any ULV testing. The blood sample will be sent to the UCSD central laboratory for processing. The patient will then undergo the scheduled ICD implant procedure as is standard clinical care. The ULV testing is performed as follows: for single coil device, a 18J shock will be delivered at 0msec, +20 msec, -20msec and -40msec measured from the peak of the T-wave; for dual coil device, a 18J shock will be delivered at 0msec, -20msec, +20msec, and +40msec measured from the peak of the T-wave. If VF is not induced with any of the above mentioned shocks, the ULV will be considered as 18J and the ICD will be implanted with the first shock strength set at 30 joules or as clinically indicated determined by treating Cardiac Electrophysiologist. If VF is induced, a 25J rescue shock will be delivered as is standard and if successful, the device will be programmed to the maximum output of 35 joules or as clinically indicated determined by treating Cardiac Electrophysiologist. Blood pressure will be monitored before and immediately after each shock. After 4 hours, 8 hours and 16 hours post ULV testing, blood samples (3 ml for Troponin-T) will be drawn and sent to the UCSD central laboratory for processing.
Other than the blood tests for Troponin-T, there is no change in routine post-operative management. Patients will be followed every three months, as is standard management for patients with ICDs.
The TnT blood draws at 4-hour, 8-hour and 16-hour post implantation will not require longer hospital stay than is standard for patients undergoing ICD implantation. The results of Troponin-T measurement for the study patients will be reviewed by the cardiac electrophysiology (EP) research staff. If myocardial injury is noted (any TnT value >0.1 as per current assay at the UCSD laboratory), the patient will be monitored as is deemed clinically necessary by treating Cardiac Electrophysiologist, including possible repeat TnT measurements for evaluation of myocardial infarction. We will follow standard of care for management of myocardial injury as recommended by the American Heart Association and the American College of Cardiology. Elevated TnT measurements may delay hospitalization, if determined to be clinically necessary. If the repeat TnT measurement is <0.1, then myocardial injury is most unlikely and the positive TnT value is likely due to DFT shocks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Defibrillation Testing | Active comparator | Device: Standard Defibrillation TestingStandard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes. |
| Upper Limit of VulnerabilityTesting | Active comparator | Device: Upper Limit of Vulnerability TestingUpper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients eligible to receive an ICD implant or change out.
- Patients with a single or dual coil right ventricle (RV) defibrillation lead located in the RV apex.
- Patients greater than 18 years of age.
- Patients willing and able to give informed consent.
- Patients who have insurance which may cover additional hospital stay if myocardial injury resulted from testing
Key exclusion criteria (2 listed)
- Patients with medical conditions that would limit study participation.
- Patients that are pregnant
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 Defibrillation TestingAlso: ICD implantationOnce the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes. | Device | Standard Defibrillation Testing |
| Upper Limit of Vulnerability TestingAlso: ICD implantationOnce the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered. | Device | Upper Limit of VulnerabilityTesting |
Primary outcome
Myocardial Damage
Time frame: 20 hours (hr)
Myocardial damage will be evaluated by cardiac troponin (cTNT) lab collection before and then after ULV or DFT testing at 4 hours, 8 hours, and 20 hours.
2 secondary outcomes
Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)
Time frame: 20 hours (hr)
Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)
Time frame: 20 hours (hr)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17338725Swerdlow CD, Shehata M, Chen PS. Using the upper limit of vulnerability to assess defibrillation efficacy at implantation of ICDs. Pacing Clin Electrophysiol. 2007 Feb;30(2):258-70. doi: 10.1111/j.1540-8159.2007.00659.x.
- Background: PubMed 17470697Day JD, Doshi RN, Belott P, Birgersdotter-Green U, Behboodikhah M, Ott P, Glatter KA, Tobias S, Frumin H, Lee BK, Merillat J, Wiener I, Wang S, Grogin H, Chun S, Patrawalla R, Crandall B, Osborn JS, Weiss JP, Lappe DL, Neuman S. Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations). Circulation. 2007 May 8;115(18):2382-9. doi: 10.1161/CIRCULATIONAHA.106.663112. Epub 2007 Apr 30.
- Background: PubMed 3698224Chen PS, Shibata N, Dixon EG, Martin RO, Ideker RE. Comparison of the defibrillation threshold and the upper limit of ventricular vulnerability. Circulation. 1986 May;73(5):1022-8. doi: 10.1161/01.cir.73.5.1022.
- Background: PubMed 8319332Chen PS, Feld GK, Kriett JM, Mower MM, Tarazi RY, Fleck RP, Swerdlow CD, Gang ES, Kass RM. Relation between upper limit of vulnerability and defibrillation threshold in humans. Circulation. 1993 Jul;88(1):186-92. doi: 10.1161/01.cir.88.1.186.
- Background: PubMed 7955188Hwang C, Swerdlow CD, Kass RM, Gang ES, Mandel WJ, Peter CT, Chen PS. Upper limit of vulnerability reliably predicts the defibrillation threshold in humans. Circulation. 1994 Nov;90(5):2308-14. doi: 10.1161/01.cir.90.5.2308.
- Background: PubMed 9083873Martin DJ, Chen PS, Hwang C, Gang ES, Mandel WJ, Peter CT, Swerdlow CD. Upper limit of vulnerability predicts chronic defibrillation threshold for transvenous implantable defibrillators. J Cardiovasc Electrophysiol. 1997 Mar;8(3):241-8. doi: 10.1111/j.1540-8167.1997.tb00786.x.
- Background: PubMed 10387143Birgersdotter-Green U, Undesser K, Fujimura O, Feld GK, Kass RM, Mandel WJ, Peter CT, Chen PS. Correlation of acute and chronic defibrillation threshold with upper limit of vulnerability determined in normal sinus rhythm. J Interv Card Electrophysiol. 1999 Jul;3(2):155-61. doi: 10.1023/a:1009825731592.
- Background: PubMed 8994950Swerdlow CD, Davie S, Ahern T, Chen PS. Comparative reproducibility of defibrillation threshold and upper limit of vulnerability. Pacing Clin Electrophysiol. 1996 Dec;19(12 Pt 1):2103-11. doi: 10.1111/j.1540-8159.1996.tb03285.x.
- Background: PubMed 8609329Swerdlow CD, Ahern T, Kass RM, Davie S, Mandel WJ, Chen PS. Upper limit of vulnerability is a good estimator of shock strength associated with 90% probability of successful defibrillation in humans with transvenous implantable cardioverter-defibrillators. J Am Coll Cardiol. 1996 Apr;27(5):1112-8. doi: 10.1016/0735-1097(95)00603-6.
- Background: PubMed 11331256Swerdlow CD. Implantation of cardioverter defibrillators without induction of ventricular fibrillation. Circulation. 2001 May 1;103(17):2159-64. doi: 10.1161/01.cir.103.17.2159.
- Background: PubMed 12652181Green UB, Garg A, Al-Kandari F, Ungab G, Tone L, Feld GK. Successful implantation of cardiac defibrillators without induction of ventricular fibrillation using upper limit of vulnerability testing. J Interv Card Electrophysiol. 2003 Feb;8(1):71-5. doi: 10.1023/a:1022304417889.
- Background: PubMed 12810611Swerdlow C, Shivkumar K, Zhang J. Determination of the upper limit of vulnerability using implantable cardioverter-defibrillator electrograms. Circulation. 2003 Jun 24;107(24):3028-33. doi: 10.1161/01.CIR.0000074220.19414.18. Epub 2003 Jun 16.
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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.
Ulrika Birgersdotter-Green, MD principal investigator
University of California, San Diego
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 Defibrillation Testing and Upper Limit of Vulnerability Testing in people with Cardiomyopathy and Heart Failure, run by University of California, San Diego 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 2 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 22 May 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?
Yes. Results are posted in the registry (first posted 22 May 2019). 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?
Myocardial Damage (time frame: 20 hours (hr)). 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 NCT02111993, which also lists 13 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 May 2019.