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Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia (ENCORE-VT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919618
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Results First Posted : September 10, 2019
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Phillip Cuculich, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ventricular Tachycardia
Cardiomyopathy
Premature Ventricular Contractions
Intervention Radiation: stereotactic body radiotherapy (SBRT)
Enrollment 19
Recruitment Details Twenty-one patients were consented between July 11, 2016 and December 20, 2017. These patients were evaluated as either inpatient or outpatient. Once patients met initial enrollment criteria, screening procedures were conducted to determine if the patient was eligible for SBRT.
Pre-assignment Details

Nineteen patients were consented, screened, and deemed eligible for SBRT.

Two additional patients signed consent and went through screening procedures; however, were later deemed ineligible to obtain SBRT.

Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description

Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

Period Title: Overall Study
Started 19
Primary Safety Endpoint (</=90 Days) [1] 19
Primary Efficacy Endpoint (6 Months) [2] 18
Completed 18
Not Completed 1
Reason Not Completed
Death             1
[1]
Phase 1 - Defined by a </=20% rate of SAEs using CTCAE v4.0 criteria.
[2]
Phase 2 - Number of subjects with a reduction in ICD therapies 6mo before and 6mo post-SBRT.
Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description

Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
66
(49 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
2
  10.5%
Male
17
  89.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.3%
White
17
  89.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
BMI  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants
33.0
(24.3 to 48.6)
Age-Adjusted Charlson Comorbidity Index   [1] 
Median (Full Range)
Unit of measure:  Score
Number Analyzed 19 participants
4
(2 to 13)
[1]
Measure Description: The Charlson Comorbidity Index predicts 10-year survival in patients with multiple comorbidities. The Charlson Comorbidity Index scale ranges from 0 (no comorbidities) to 37 (all comorbidities in equation). The score is then adjusted based on the age of the patient, adding 0 to 4 points to the Charlson Comorbidity Index score, thus providing the Age-Adjusted Charlson Comorbidity Index.
Type of Cardiomyopathy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Ischemic Cardiomyopathy
11
  57.9%
Nonischemic Cardiomyopathy
8
  42.1%
Type of Nonischemic Cardiomyopathy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Idiopathic
5
  62.5%
Myocarditis (Chronic)
2
  25.0%
Valvular
1
  12.5%
[1]
Measure Analysis Population Description: Based on the number of patients enrolled with nonischemic cardiomyopathy (8/19).
New York Heart Association (NYHA) Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
NYHA I
1
   5.3%
NYHA II
4
  21.1%
NYHA III
10
  52.6%
NYHA IV
4
  21.1%
[1]
Measure Description: NYHA Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea; NYHA Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea; NYHA Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea; NYHA Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Left Ventricular Ejection Fraction  
Median (Full Range)
Unit of measure:  Percentage of Ejection Fraction
Number Analyzed 19 participants
25
(15 to 58)
Number of Previous Catheter Ablations  
Median (Full Range)
Unit of measure:  Invasive Procedures
Number Analyzed 19 participants
1
(0 to 4)
Total Number of Prior Catheter Ablation Approaches  
Measure Type: Number
Unit of measure:  Invasive Ablation Approaches
Endocardial Number Analyzed 19 participants
25
Epicardial Number Analyzed 19 participants
4
Study Eligibility Criteria  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Incessant Ventricular Tachycardia (VT)
2
  10.5%
VT Storm (>3 episodes of VT in 24 hours)
10
  52.6%
ICD Therapies (>3 shocks or ATP in 6 months)
5
  26.3%
PVC-Related Cardiomyopathy
2
  10.5%
Device  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Single- or Dual-Chamber ICD
8
  42.1%
Biventricular ICD
10
  52.6%
No Device
1
   5.3%
Current Antiarrhythmic Drugs  
Measure Type: Number
Unit of measure:  Count of Participants
>1 Antiarrhythmic Drug at Baseline Number Analyzed 19 participants
11
High-Dose Amiodarone (>/=300mg per day) Number Analyzed 19 participants
10
Low-Dose Amiodarone (<300mg per day) Number Analyzed 19 participants
2
Class III (excluding amiodarone) Number Analyzed 19 participants
7
Class I Number Analyzed 19 participants
11
Other Medications  
Measure Type: Number
Unit of measure:  Count of Participants
Beta Blocker Number Analyzed 19 participants
18
Angiotensin Converting Enzyme Inhibitor Number Analyzed 19 participants
10
Angiotensin Receptor Blocker Number Analyzed 19 participants
7
Oral Anticoagulation Number Analyzed 19 participants
14
Variable  
Measure Type: Number
Unit of measure:  Count of Participants
Chronic Obstructive Pulmonary Disease/Emphysema Number Analyzed 19 participants
4
Diabetes Mellitus, Type II Number Analyzed 19 participants
7
Hypertension Number Analyzed 19 participants
10
Chronic Kidney Disease (Stage >/=3) Number Analyzed 19 participants
9
1.Primary Outcome
Title Number of Serious Adverse Events
Hide Description Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.
Time Frame < or = 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on number of SAE events that occurred in 19 participants within 90 days after SBRT.
Arm/Group Title Number of Events
Hide Arm/Group Description:
Number of serious adverse events that occurred.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Events
Grade 3 treatment-related SAE 2
Grade 4 treatment-related SAE 0
Grade 5 treatment-related SAE 0
Grade 5 SAE (not treatment-related) 1
2.Primary Outcome
Title Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden
Hide Description Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors.
Time Frame 12 months (6mo prior to and 6mo post SBRT)
Hide Outcome Measure Data
Hide Analysis Population Description

Percent reduction of VT episodes or PVC burden 6 months post-SBRT compared to 6 months prior to SBRT.

Patients who were alive at 6 months were evaluated comparing ICD treatments or PVC burden 6 months before and 6 months post-SBRT.

Arm/Group Title Patients With ICD-treated VT Indication Patients With PVC-Related Cardiomyopathy Indication
Hide Arm/Group Description:
Sixteen evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with an ICD-treated VT indication.
Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.
Overall Number of Participants Analyzed 16 2
Measure Type: Count of Participants
Unit of Measure: Participants
15
  93.8%
2
 100.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 6 Month Overall Survival 12 Month Overall Survival
Hide Arm/Group Description:
Overall survival at the 6 month post-SBRT time point of all 19 patients enrolled.
Overall survival at the 12 month post-SBRT time point of the 18 remaining patients from the 6 month time point.
Overall Number of Participants Analyzed 19 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
  94.7%
13
  72.2%
4.Secondary Outcome
Title Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment
Hide Description Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.
Time Frame 90 days to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on number of AE events that occurred in 18 participants >90 days to 365 days post-SBRT.
Arm/Group Title Number of Events
Hide Arm/Group Description:
Number of adverse events that occurred.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Number of Events
Grade 1 Possibly Related AE 15
Grade 1 Probably Related AE 1
Grade 2 Possibly Related AE 9
Grade 2 Probably Related AE 1
Grade 2 Definitely Related AE 1
Grade 3 Possibly Related AE 20
Grade 4 Possibly Related AE 1
Grade 5 Possibly Related AE 1
5.Secondary Outcome
Title Health Related Quality of Life (HRQOL)
Hide Description The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.
Time Frame 6 week, 6 month, 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline 6 Week 6 Month 12 Month
Hide Arm/Group Description:
Baseline mean scores for all 18 evaluable patients at the 6 week time point.
6 week mean scores for all 18 evaluable patients at the 6 week time point.
6 month mean scores for all 16 evaluable patients at the 6 month time point. 2 patients did not return the SF-36 survey for the 6 month follow up.
12 month mean scores for all 13 evaluable patients at the 12 month time point. 5 patients had expired prior to the 12 month time point.
Overall Number of Participants Analyzed 18 18 16 13
Mean (Full Range)
Unit of Measure: Scores on a Scale
Social Functioning
64
(25 to 100)
70
(13 to 100)
87
(50 to 100)
72
(38 to 100)
General Health
44
(10 to 85)
52
(15 to 95)
49
(6 to 90)
54
(15 to 85)
Health Change
28
(0 to 75)
61
(25 to 100)
77
(0 to 100)
65
(0 to 100)
6.Secondary Outcome
Title Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden
Hide Description Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be >50% reduction in PVC burden based on ambulatory heart monitors.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was excluded because they expired prior to the outcome measure time frame.
Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description:

Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
17
  94.4%
7.Secondary Outcome
Title Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden
Hide Description Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (<1%) based on ambulatory heart monitors.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was excluded because they expired prior to the outcome measure time frame.
Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description:

Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  61.1%
8.Secondary Outcome
Title Number of Participants With Reduction in ICD Shocks and LVEF Improvement
Hide Description Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was excluded because they expired prior to the outcome measure time frame.
Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description:

Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
13
  72.2%
9.Secondary Outcome
Title Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months
Hide Description Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description:

Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
16
  88.9%
Time Frame Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Overall Who Received SBRT
Hide Arm/Group Description

Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy)

All-Cause Mortality
Patients Overall Who Received SBRT
Affected / at Risk (%)
Total   8/19 (42.11%) 
Hide Serious Adverse Events
Patients Overall Who Received SBRT
Affected / at Risk (%)
Total   15/19 (78.95%) 
Blood and lymphatic system disorders   
Anemia  1  1/19 (5.26%) 
Cardiac disorders   
Atrial Fibrillation  1  1/19 (5.26%) 
Cardiac Arrest  1  3/19 (15.79%) 
Heart Failure  1  6/19 (31.58%) 
Other - Chest Pain NOS  1  2/19 (10.53%) 
Other - ICD Lead Fracture  1  1/19 (5.26%) 
Palpitations  1  1/19 (5.26%) 
Pericardial Effusion  1  2/19 (10.53%) 
Pericarditis  1  1/19 (5.26%) 
Ventricular Fibrillation  1  1/19 (5.26%) 
Ventricular Tachycardia  1  9/19 (47.37%) 
Gastrointestinal disorders   
Diarrhea  1  1/19 (5.26%) 
Gastric Hemorrhage  1  1/19 (5.26%) 
Retroperitoneal Hemorrhage  1  1/19 (5.26%) 
General disorders   
Multi-organ Failure  1  1/19 (5.26%) 
Other - Accident  1  1/19 (5.26%) 
Hepatobiliary disorders   
Cholecystitis  1  1/19 (5.26%) 
Hepatic Failure  1  1/19 (5.26%) 
Infections and infestations   
Urinary Tract Infection  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Intraoperative Cardiac Injury  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Acidosis  1  1/19 (5.26%) 
Dehydration  1  1/19 (5.26%) 
Nervous system disorders   
Cognitive Disturbance  1  1/19 (5.26%) 
Renal and urinary disorders   
Acute Kidney Injury  1  2/19 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/19 (10.53%) 
Hypoxia  1  2/19 (10.53%) 
Other - Chemical Pneumonitis  1 [1]  1/19 (5.26%) 
Other - Pneumonia  1  2/19 (10.53%) 
Pneumothorax  1  1/19 (5.26%) 
Respiratory Failure  1  2/19 (10.53%) 
Vascular disorders   
Flushing  1  1/19 (5.26%) 
Hematoma  1  1/19 (5.26%) 
Hypertension  1  1/19 (5.26%) 
Hypotension  1  3/19 (15.79%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Amiodarone Induced
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients Overall Who Received SBRT
Affected / at Risk (%)
Total   19/19 (100.00%) 
Cardiac disorders   
Acute Coronary Syndrome  1  1/19 (5.26%) 
Atrial Fibrillation  1  2/19 (10.53%) 
Heart Failure  1  8/19 (42.11%) 
Mitral Valve Disease  1 [1]  1/19 (5.26%) 
Other - Chest Pain NOS  1  8/19 (42.11%) 
Palpitations  1  1/19 (5.26%) 
Pericardial Effusion  1  5/19 (26.32%) 
Pericarditis  1  1/19 (5.26%) 
Sinus Tachycardia  1  1/19 (5.26%) 
Ventricular Fibrillation  1  1/19 (5.26%) 
Ear and labyrinth disorders   
Ear Pain  1  1/19 (5.26%) 
Gastrointestinal disorders   
Abdominal Pain  1  2/19 (10.53%) 
Colitis  1  1/19 (5.26%) 
Constipation  1  1/19 (5.26%) 
Dyspepsia  1  6/19 (31.58%) 
Nausea  1  6/19 (31.58%) 
Other - Congestive Gastropathy  1  1/19 (5.26%) 
Other - Dark Stools  1  1/19 (5.26%) 
Other - Gastroenteritis  1  1/19 (5.26%) 
Other - Polydipsia  1  1/19 (5.26%) 
Retroperitoneal Hemorrhage  1  1/19 (5.26%) 
Stomach Pain  1  1/19 (5.26%) 
Vomiting  1  5/19 (26.32%) 
General disorders   
Chills  1  1/19 (5.26%) 
Fatigue  1  12/19 (63.16%) 
Malaise  1  1/19 (5.26%) 
Hepatobiliary disorders   
Cholecystitis  1  1/19 (5.26%) 
Immune system disorders   
Allergic Reaction  1 [2]  1/19 (5.26%) 
Infections and infestations   
Sepsis  1  1/19 (5.26%) 
Sinusitis  1  1/19 (5.26%) 
Upper Respiratory Infection  1  3/19 (15.79%) 
Urinary Tract Infection  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Ankle Fracture  1  1/19 (5.26%) 
Fracture  1  1/19 (5.26%) 
Investigations   
Alanine Aminotransferase Increased  1  1/19 (5.26%) 
Alkaline Phosphatase Increased  1  1/19 (5.26%) 
Aspartate Aminotransferase Increased  1  1/19 (5.26%) 
Blood Bilirubin Increased  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/19 (5.26%) 
Back Pain  1  4/19 (21.05%) 
Chest Wall Pain  1  1/19 (5.26%) 
Other - Shoulder Pain  1  1/19 (5.26%) 
Other - Tendon Rupture  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cyst  1  1/19 (5.26%) 
Nervous system disorders   
Dizziness  1  9/19 (47.37%) 
Dysesthesia  1  3/19 (15.79%) 
Headache  1  2/19 (10.53%) 
Hypersomnia  1  1/19 (5.26%) 
Paresthesia  1  1/19 (5.26%) 
Presyncope  1  1/19 (5.26%) 
Seizure  1  1/19 (5.26%) 
Spacticity  1  1/19 (5.26%) 
Syncope  1  1/19 (5.26%) 
Tremors  1 [3]  1/19 (5.26%) 
Psychiatric disorders   
Agitation  1  1/19 (5.26%) 
Renal and urinary disorders   
Acute Kidney Injury  1  1/19 (5.26%) 
Hematuria  1  2/19 (10.53%) 
Other - Dysuria  1  1/19 (5.26%) 
Other - Nephrolithiasis  1  1/19 (5.26%) 
Reproductive system and breast disorders   
Testicular Pain  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/19 (15.79%) 
Dyspnea  1  8/19 (42.11%) 
Hypoxia  1  1/19 (5.26%) 
Other - Influenza  1  1/19 (5.26%) 
Other - Pneumonia  1  2/19 (10.53%) 
Other - Radiation Pneumonitis  1  2/19 (10.53%) 
Pleural Effusion  1  2/19 (10.53%) 
Pleuritic Pain  1  1/19 (5.26%) 
Pulmonary Edema  1  1/19 (5.26%) 
Wheezing  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  2/19 (10.53%) 
Vascular disorders   
Hematoma  1  1/19 (5.26%) 
Hypertension  1  1/19 (5.26%) 
Hypotension  1  8/19 (42.11%) 
Thromboembolic Event  1  1/19 (5.26%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Progression of existing mitral regurgitation
[2]
Due to MRI contrast
[3]
Amiodarone Induced
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Phillip Cuculich
Organization: Washington University
Phone: 314-454-7698
EMail: pcuculic@wustl.edu
Layout table for additonal information
Responsible Party: Phillip Cuculich, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02919618    
Other Study ID Numbers: 201606081
First Submitted: September 28, 2016
First Posted: September 29, 2016
Results First Submitted: July 1, 2019
Results First Posted: September 10, 2019
Last Update Posted: December 2, 2021