Trial Outcomes & Findings for Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia (NCT NCT02919618)

NCT ID: NCT02919618

Last Updated: 2024-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

< or = 90 days

Results posted on

2024-08-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Patients Overall Who Received SBRT 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 Study STARTED	19
Overall Study Primary Safety Endpoint (</=90 Days)	19
Overall Study Primary Efficacy Endpoint (6 Months)	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Overall Who Received SBRT 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 Study Death	1

Baseline Characteristics

Based on the number of patients enrolled with nonischemic cardiomyopathy (8/19).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Overall Who Received SBRT n=19 Participants 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)
Age, Continuous	66 years n=19 Participants
Sex: Female, Male Female	2 Participants n=19 Participants
Sex: Female, Male Male	17 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=19 Participants
Race (NIH/OMB) Asian	1 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	1 Participants n=19 Participants
Race (NIH/OMB) White	17 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants
BMI	33.0 kg/m^2 n=19 Participants
Age-Adjusted Charlson Comorbidity Index	4 Score n=19 Participants
Type of Cardiomyopathy Ischemic Cardiomyopathy	11 Participants n=19 Participants
Type of Cardiomyopathy Nonischemic Cardiomyopathy	8 Participants n=19 Participants
Type of Nonischemic Cardiomyopathy Idiopathic	5 Participants n=8 Participants • Based on the number of patients enrolled with nonischemic cardiomyopathy (8/19).
Type of Nonischemic Cardiomyopathy Myocarditis (Chronic)	2 Participants n=8 Participants • Based on the number of patients enrolled with nonischemic cardiomyopathy (8/19).
Type of Nonischemic Cardiomyopathy Valvular	1 Participants n=8 Participants • Based on the number of patients enrolled with nonischemic cardiomyopathy (8/19).
New York Heart Association (NYHA) Class NYHA I	1 Participants n=19 Participants
New York Heart Association (NYHA) Class NYHA II	4 Participants n=19 Participants
New York Heart Association (NYHA) Class NYHA III	10 Participants n=19 Participants
New York Heart Association (NYHA) Class NYHA IV	4 Participants n=19 Participants
Left Ventricular Ejection Fraction	25 Percentage of Ejection Fraction n=19 Participants
Number of Previous Catheter Ablations	1 Invasive Procedures n=19 Participants
Total Number of Prior Catheter Ablation Approaches Endocardial	25 Invasive Ablation Approaches n=19 Participants
Total Number of Prior Catheter Ablation Approaches Epicardial	4 Invasive Ablation Approaches n=19 Participants
Study Eligibility Criteria Incessant Ventricular Tachycardia (VT)	2 Participants n=19 Participants
Study Eligibility Criteria VT Storm (>3 episodes of VT in 24 hours)	10 Participants n=19 Participants
Study Eligibility Criteria ICD Therapies (>3 shocks or ATP in 6 months)	5 Participants n=19 Participants
Study Eligibility Criteria PVC-Related Cardiomyopathy	2 Participants n=19 Participants
Device Single- or Dual-Chamber ICD	8 Participants n=19 Participants
Device Biventricular ICD	10 Participants n=19 Participants
Device No Device	1 Participants n=19 Participants
Current Antiarrhythmic Drugs >1 Antiarrhythmic Drug at Baseline	11 Count of Participants n=19 Participants
Current Antiarrhythmic Drugs High-Dose Amiodarone (>/=300mg per day)	10 Count of Participants n=19 Participants
Current Antiarrhythmic Drugs Low-Dose Amiodarone (<300mg per day)	2 Count of Participants n=19 Participants
Current Antiarrhythmic Drugs Class III (excluding amiodarone)	7 Count of Participants n=19 Participants
Current Antiarrhythmic Drugs Class I	11 Count of Participants n=19 Participants
Other Medications Beta Blocker	18 Count of Participants n=19 Participants
Other Medications Angiotensin Converting Enzyme Inhibitor	10 Count of Participants n=19 Participants
Other Medications Angiotensin Receptor Blocker	7 Count of Participants n=19 Participants
Other Medications Oral Anticoagulation	14 Count of Participants n=19 Participants
Variable Chronic Obstructive Pulmonary Disease/Emphysema	4 Count of Participants n=19 Participants
Variable Diabetes Mellitus, Type II	7 Count of Participants n=19 Participants
Variable Hypertension	10 Count of Participants n=19 Participants
Variable Chronic Kidney Disease (Stage >/=3)	9 Count of Participants n=19 Participants

PRIMARY outcome

Timeframe: < or = 90 days

Population: Analysis is based on number of SAE events that occurred in 19 participants within 90 days after SBRT.

Outcome measures

Outcome measures
Measure	Number of Events n=19 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Serious Adverse Events Grade 3 treatment-related SAE	2 Events	—	—	—
Number of Serious Adverse Events Grade 4 treatment-related SAE	0 Events	—	—	—
Number of Serious Adverse Events Grade 5 treatment-related SAE	0 Events	—	—	—
Number of Serious Adverse Events Grade 5 SAE (not treatment-related)	1 Events	—	—	—

PRIMARY outcome

Timeframe: 12 months (6mo prior to and 6mo post SBRT)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Number of Events n=16 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication n=2 Participants Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden	15 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 12 months

Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.

Outcome measures

Outcome measures
Measure	Number of Events n=19 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication n=18 Participants Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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 Survival	18 Participants	13 Participants	—	—

SECONDARY outcome

Timeframe: 90 days to 12 months

Population: Analysis is based on number of AE events that occurred in 18 participants \>90 days to 365 days post-SBRT.

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.

Outcome measures

Outcome measures
Measure	Number of Events n=19 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 5 Possibly Related AE	1 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 1 Possibly Related AE	15 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 1 Probably Related AE	1 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 2 Possibly Related AE	9 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 2 Probably Related AE	1 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 2 Definitely Related AE	1 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 3 Possibly Related AE	20 Number of Events	—	—	—
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment Grade 4 Possibly Related AE	1 Number of Events	—	—	—

SECONDARY outcome

Timeframe: 6 week, 6 month, 12 month

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.

Outcome measures

Outcome measures
Measure	Number of Events n=18 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication n=18 Participants Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month n=16 Participants 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 n=13 Participants 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.
Health Related Quality of Life (HRQOL) Health Change	28 Scores on a Scale Interval 0.0 to 75.0	61 Scores on a Scale Interval 25.0 to 100.0	77 Scores on a Scale Interval 0.0 to 100.0	65 Scores on a Scale Interval 0.0 to 100.0
Health Related Quality of Life (HRQOL) Social Functioning	64 Scores on a Scale Interval 25.0 to 100.0	70 Scores on a Scale Interval 13.0 to 100.0	87 Scores on a Scale Interval 50.0 to 100.0	72 Scores on a Scale Interval 38.0 to 100.0
Health Related Quality of Life (HRQOL) General Health	44 Scores on a Scale Interval 10.0 to 85.0	52 Scores on a Scale Interval 15.0 to 95.0	49 Scores on a Scale Interval 6.0 to 90.0	54 Scores on a Scale Interval 15.0 to 85.0

SECONDARY outcome

Timeframe: 6 months

Population: One patient was excluded because they expired prior to the outcome measure time frame.

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.

Outcome measures

Outcome measures
Measure	Number of Events n=18 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden	17 Participants	—	—	—

SECONDARY outcome

Timeframe: 6 months

Population: One patient was excluded because they expired prior to the outcome measure time frame.

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.

Outcome measures

Outcome measures
Measure	Number of Events n=18 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden	11 Participants	—	—	—

SECONDARY outcome

Timeframe: 6 months

Population: One patient was excluded because they expired prior to the outcome measure time frame.

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.

Outcome measures

Outcome measures
Measure	Number of Events n=18 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Participants With Reduction in ICD Shocks and LVEF Improvement	13 Participants	—	—	—

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Number of Events n=18 Participants Number of serious adverse events that occurred.	Patients With PVC-Related Cardiomyopathy Indication Two evaluable patients out of the overall 18 patients alive at 6 months who were enrolled with a PVC indication.	6 Month 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 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.
Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months	16 Participants	—	—	—

Adverse Events

Patients Overall Who Received SBRT

Serious events: 15 serious events

Other events: 19 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Patients Overall Who Received SBRT n=19 participants at risk 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)
Metabolism and nutrition disorders Acidosis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Renal and urinary disorders Acute Kidney Injury	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Blood and lymphatic system disorders Anemia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Atrial Fibrillation	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Cardiac Arrest	15.8% 3/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Hepatobiliary disorders Cholecystitis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Cognitive Disturbance	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Diarrhea	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Flushing	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Gastric Hemorrhage	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Heart Failure	31.6% 6/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Hematoma	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Hepatobiliary disorders Hepatic Failure	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Hypertension	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Hypotension	15.8% 3/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Injury, poisoning and procedural complications Intraoperative Cardiac Injury	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
General disorders Multi-organ Failure	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
General disorders Other - Accident	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Other - Chemical Pneumonitis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Other - Chest Pain NOS	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Other - Pneumonia	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Other - ICD Lead Fracture	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Palpitations	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Pericardial Effusion	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Pericarditis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Retroperitoneal Hemorrhage	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Infections and infestations Urinary Tract Infection	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Ventricular Fibrillation	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Ventricular Tachycardia	47.4% 9/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.

Other adverse events

Other adverse events
Measure	Patients Overall Who Received SBRT n=19 participants at risk 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)
Cardiac disorders Ventricular Fibrillation	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Vomiting	26.3% 5/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Wheezing	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Abdominal Pain	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Acute Coronary Syndrome	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Renal and urinary disorders Acute Kidney Injury	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Psychiatric disorders Agitation	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Investigations Alanine Aminotransferase Increased	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Investigations Alkaline Phosphatase Increased	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Immune system disorders Allergic Reaction	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Injury, poisoning and procedural complications Ankle Fracture	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Musculoskeletal and connective tissue disorders Arthritis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Investigations Aspartate Aminotransferase Increased	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Atrial Fibrillation	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Musculoskeletal and connective tissue disorders Back Pain	21.1% 4/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Investigations Blood Bilirubin Increased	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Musculoskeletal and connective tissue disorders Chest Wall Pain	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
General disorders Chills	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Hepatobiliary disorders Cholecystitis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Colitis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Constipation	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Cough	15.8% 3/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Dizziness	47.4% 9/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Dysesthesia	15.8% 3/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Dyspepsia	31.6% 6/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Dyspnea	42.1% 8/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Ear and labyrinth disorders Ear Pain	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
General disorders Fatigue	63.2% 12/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Injury, poisoning and procedural complications Fracture	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Headache	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Heart Failure	42.1% 8/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Hematoma	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Renal and urinary disorders Hematuria	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Metabolism and nutrition disorders Hyperglycemia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Skin and subcutaneous tissue disorders Hyperhidrosis	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Hypersomnia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Hypertension	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Hypotension	42.1% 8/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
General disorders Malaise	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Mitral Valve Disease	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Nausea	31.6% 6/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Other - Chest Pain NOS	42.1% 8/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Other - Congestive Gastropathy	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Other - Dark Stools	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Renal and urinary disorders Other - Dysuria	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Other - Gastroenteritis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Other - Influenza	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Renal and urinary disorders Other - Nephrolithiasis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Other - Pneumonia	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Other - Polydipsia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Other - Radiation Pneumonitis	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Musculoskeletal and connective tissue disorders Other - Shoulder Pain	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Musculoskeletal and connective tissue disorders Other - Tendon Rupture	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Palpitations	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Paresthesia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Pericardial Effusion	26.3% 5/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Pericarditis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	10.5% 2/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Presyncope	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Retroperitoneal Hemorrhage	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Seizure	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Infections and infestations Sepsis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Cardiac disorders Sinus Tachycardia	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Infections and infestations Sinusitis	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Spacticity	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Gastrointestinal disorders Stomach Pain	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Syncope	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Reproductive system and breast disorders Testicular Pain	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Vascular disorders Thromboembolic Event	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Nervous system disorders Tremors	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Infections and infestations Upper Respiratory Infection	15.8% 3/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
Infections and infestations Urinary Tract Infection	5.3% 1/19 • Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.

Additional Information

Dr. Phillip Cuculich

Washington University

Phone: 314-454-7698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place