Clincosm LogoSign in Get a demo

ULV: Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT02111993
Collaborator
Medtronic (Industry)
60
Enrollment
1
Location
2
Arms
46
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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. standard defibrillation threshold method.

Condition or Disease Intervention/Treatment Phase
  • Device: Standard Defibrillation Testing
  • Device: Upper Limit of Vulnerability Testing
 N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluating Myocardial Injury During ICD Implantation Using the Upper Limit of Vulnerability (ULV) Method vs. Standard Defibrillation Threshold Testing
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Defibrillation Testing

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.

Device: Standard Defibrillation Testing
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.
Other Names:
  • ICD implantation

    		•
    Active Comparator: Upper Limit of VulnerabilityTesting

    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.

    Device: Upper Limit of Vulnerability Testing
    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.
    Other Names:
  • ICD implantation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Myocardial Damage [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.

    Secondary Outcome Measures

    1. Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced) [20 hours (hr)]

      the DFT group cardiac troponin (cTNT) values were compared to the subjects within the ULV group that required VF induction.

    2. Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced) [20 hours (hr)]

      The DFT group was compared to the ULV subgroup that did not require ventricular fibrillation (VF) induction. Cardiac troponin (cTNT) levels were analyzed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Patients with medical conditions that would limit study participation.

    • Patients that are pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSD Sulpizio Cardiovascular Center La Jolla California United States 92093

    Sponsors and Collaborators

    • University of California, San Diego
    • Medtronic

    Investigators

    • Principal Investigator: Ulrika Birgersdotter-Green, MD, University of California, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ulrika Birgersdotter-Green, Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT02111993
    Other Study ID Numbers:
    • 110647
    First Posted:
    Apr 11, 2014
    Last Update Posted:
    May 22, 2019
    Last Verified:
    May 1, 2019
    Keywords provided by Ulrika Birgersdotter-Green, Professor, University of California, San Diego
    Defibrillation testing
    Upper Limit of Vulnerability
    ULV
    DFT
    ICD
    implantable cardioverter defibrillator
    cardiomyopathy
    cardiac arrhythmia
    cardiac device testing
    Additional relevant MeSH terms:
    Cardiomyopathies
    Arrhythmias, Cardiac

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 60 patients were consented and enrolled in this trial. 9 of which were withdrawn due to incomplete lab draws. 51 patients successfully completed study procedures and were included in the study data analysis.
    Arm/Group Title Standard Defibrillation Testing Upper Limit of VulnerabilityTesting
    Arm/Group Description 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. Standard Defibrillation Testing: 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 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. Upper Limit of Vulnerability Testing: 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.
    Period Title: Overall Study
    STARTED 30 30
    COMPLETED 25 26
    NOT COMPLETED 5 4

    Baseline Characteristics

    Arm/Group Title Standard Defibrillation Testing Upper Limit of VulnerabilityTesting Total
    Arm/Group Description 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. Standard Defibrillation Testing: 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 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. Upper Limit of Vulnerability Testing: 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. Total of all reporting groups
    Overall Participants 25 26 51
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67
    (16)
    63
    (11)
    65
    (14)
    Sex: Female, Male (Count of Participants)
    Female
    6
    24%
    5
    19.2%
    11
    21.6%
    Male
    19
    76%
    21
    80.8%
    40
    78.4%
    Region of Enrollment (participants) [Number]
    United States
    25
    100%
    26
    100%
    51
    100%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    28.2
    (7.0)
    27.4
    (4.6)
    27.8
    (5.1)
    History of Hypertension (HTN) (participants) [Number]
    Number [participants]
    16
    64%
    12
    46.2%
    28
    54.9%
    Presence of Left Ventricular Hypertrophy (LVH) (participants) [Number]
    Number [participants]
    9
    36%
    17
    65.4%
    26
    51%
    History of Ventricular Tachycardia (VT) (participants) [Number]
    Number [participants]
    8
    32%
    10
    38.5%
    18
    35.3%
    History of Non-Ischemic Cardiomyopathy (NICM) (participants) [Number]
    Number [participants]
    2
    8%
    6
    23.1%
    8
    15.7%
    History of Diabetes Mellitus (DM) (participants) [Number]
    Number [participants]
    5
    20%
    6
    23.1%
    11
    21.6%
    History of Coronary Artery Bypass Graft (CABG) (participants) [Number]
    Number [participants]
    4
    16%
    1
    3.8%
    5
    9.8%
    Secondary Prevention Implanted Cardiac Defibrillator (ICD) (participants) [Number]
    Number [participants]
    2
    8%
    1
    3.8%
    3
    5.9%
    Anti-Arrhythmic Medication (participants) [Number]
    Number [participants]
    5
    20%
    6
    23.1%
    11
    21.6%
    Beta-Blocker Medication (participants) [Number]
    Number [participants]
    15
    60%
    19
    73.1%
    34
    66.7%
    Ejection Fraction (EF) (%) (percentage) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percentage]
    40
    (17)
    34
    (18)
    38
    (17.6)
    End Diastolic Volume (EDV) (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    5.4
    (0.9)
    5.5
    (1.1)
    5.45
    (1.0)
    Dual Coil ICD (participants) [Number]
    Number [participants]
    12
    48%
    10
    38.5%
    22
    43.1%
    Single Coil ICD (participants) [Number]
    Number [participants]
    13
    52%
    10
    38.5%
    23
    45.1%

    Outcome Measures

    1. Primary Outcome
    Title Myocardial Damage
    Description 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.
    Time Frame 20 hours (hr)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Defibrillation Testing Upper Limit of VulnerabilityTesting
    Arm/Group Description 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. Standard Defibrillation Testing: 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 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. Upper Limit of Vulnerability Testing: 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.
    Measure Participants 25 26
    Δ4 hr cTnT
    0.001
    (0.023)
    0.011
    (0.066)
    Δ8 hr cTnT
    0.002
    (0.030)
    0.012
    (0.072)
    Δ20 hr cTnT
    0.002
    (0.032)
    0.001
    (0.048)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments This p-value correlates to Δ4 hr cTnT
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments This p-value correlates to Δ8 hr cTnT.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments This p-value correlates to Δ20 hr cTnT
    Method t-test, 2 sided
    Comments
    2. Secondary Outcome
    Title Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)
    Description the DFT group cardiac troponin (cTNT) values were compared to the subjects within the ULV group that required VF induction.
    Time Frame 20 hours (hr)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Defibrillation Testing Upper Limit of VulnerabilityTesting (VF Induced)
    Arm/Group Description 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. Standard Defibrillation Testing: 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 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. Upper Limit of Vulnerability Testing: 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. VF was induced in a subset of the ULV patients, and a 25 J rescue shock was delivered.
    Measure Participants 25 11
    Δ4 hr cTnT
    0.001
    (0.023)
    0.075
    (0.086)
    Δ8 hr cTnT
    0.002
    (0.030)
    0.078
    (0.093)
    Δ20 hr cTnT
    0.002
    (0.032)
    0.042
    (0.057)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.04
    Comments This p-value correlates to Δ4 hr cTnT
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments This p-value correlates to Δ8 hr cTnT
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments This p-value correlates to Δ20 hr cTnT
    Method t-test, 2 sided
    Comments
    3. Secondary Outcome
    Title Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)
    Description The DFT group was compared to the ULV subgroup that did not require ventricular fibrillation (VF) induction. Cardiac troponin (cTNT) levels were analyzed.
    Time Frame 20 hours (hr)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard Defibrillation Testing Upper Limit of VulnerabilityTesting (No VF Induction)
    Arm/Group Description 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. Standard Defibrillation Testing: 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 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. Upper Limit of Vulnerability Testing: 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. VF was not induced in this subgroup with any of these shocks, and the ULV was considered to be 18J.
    Measure Participants 25 14
    Δ4 hr cTnT
    0.001
    (0.023)
    0.031
    (0.031)
    Δ8 hr cTnT
    0.002
    (0.030)
    0.038
    (0.038)
    Δ20 hr cTnT
    0.002
    (0.032)
    0.031
    (0.031)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.17
    Comments This p-value correlates to Δ4 hr cTnT
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.19
    Comments This p-value correlates to Δ8 hr cTnT
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Standard Defibrillation Testing, Upper Limit of VulnerabilityTesting
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments This p-value correlates to Δ20 hr cTnT
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Standard Defibrillation Testing Upper Limit of VulnerabilityTesting
    Arm/Group Description 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. Standard Defibrillation Testing: 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 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. Upper Limit of Vulnerability Testing: 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.
    All Cause Mortality
    Standard Defibrillation Testing Upper Limit of VulnerabilityTesting
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Standard Defibrillation Testing Upper Limit of VulnerabilityTesting
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Standard Defibrillation Testing Upper Limit of VulnerabilityTesting
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Ulrika Birgersdotter-Green, MD
    Organization UC San Diego School of Medicine
    Phone 858-657-5310
    Email ubgreen@ucsd.edu
    Responsible Party:
    Ulrika Birgersdotter-Green, Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT02111993
    Other Study ID Numbers:
    • 110647
    First Posted:
    Apr 11, 2014
    Last Update Posted:
    May 22, 2019
    Last Verified:
    May 1, 2019