Trial Outcomes & Findings for REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation (NCT NCT01858194)

NCT ID: NCT01858194

Last Updated: 2020-04-17

Results Overview

Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2020-04-17

Participant Flow

21 participants received ID numbers because they were consented. 3 patients were screen failures due to accessibility of renal vasculature and Investigator discretion. 1 patient was a non-randomized roll- in where data was not collected.

Participant milestones

Measure	VT Ablation Alone VT ablation alone: Placebo arm will receive standard VT ablation using current techniques	Renal Sympathetic Denervation Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).
Overall Study STARTED	8	9
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	VT Ablation Alone VT ablation alone: Placebo arm will receive standard VT ablation using current techniques	Renal Sympathetic Denervation Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).
Overall Study Total Artificial Heart Implant	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Baseline characteristics by cohort

Measure	VT Ablation Alone n=8 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques	Renal Sympathetic Denervation n=9 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	Total n=17 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 8.73 • n=5 Participants	56.78 years STANDARD_DEVIATION 9.43 • n=7 Participants	58.88 years STANDARD_DEVIATION 9.12 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months

Outcome measures

Measure	Renal Sympathetic Denervation n=9 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=8 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Freedom From First Event Requiring ICD Therapy 12 months	62.5 probability of freedom	50 probability of freedom
Freedom From First Event Requiring ICD Therapy 24 months	62.5 probability of freedom	37.5 probability of freedom

SECONDARY outcome

Timeframe: at 24 months

An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Appropriate ICD Shocks for Ventricular Arrhythmia	7 occurrences	12 occurrences

SECONDARY outcome

Timeframe: at 24 months

Number of inappropriate ICD therapy including both appropriate and inappropriate shocks

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Inappropriate ICD Therapy	5 occurrences	7 occurrences

SECONDARY outcome

Timeframe: 24 months

cumulative ICD therapies including both appropriate and inappropriate shocks

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
All ICD Therapies (Appropriate + Inappropriate)	32 occurrences	32 occurrences

SECONDARY outcome

Timeframe: 24 months

Number of Participants with a composite of Mortality, ICD storm, and Incessant VT

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Participants With Mortality, ICD Storm and Incessant VT	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Participants With Hospitalizations for Cardiovascular Causes	3 Participants	1 Participants

SECONDARY outcome

Timeframe: at 24 months

Total VT burden (Number of episodes)

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Episodes of Total VT Burden	20 episodes	12 episodes

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Participants With All-Cause Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Participants With Occurrences of ICD Storm	1 Participants	3 Participants

SECONDARY outcome

Timeframe: at baseline and at 12 months

Population: results only for those participants who have both timepoint data

Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.

Outcome measures

Measure	Renal Sympathetic Denervation n=3 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=2 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Change in Brain Natriuretic Peptide (BNP)	-12.33 mg/dL Standard Deviation 46.6	-2.5 mg/dL Standard Deviation 24.75

SECONDARY outcome

Timeframe: baseline and 12 months

Population: Results only available for participants with data for both timepoints.

Differences in BUN/creatinine measurements compared at 12 months to baseline.

Outcome measures

Measure	Renal Sympathetic Denervation n=4 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=3 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Differences in BUN/Creatinine Measurements BUN	-4 mg/dL Standard Deviation 4.84	1.67 mg/dL Standard Deviation 5.68
Differences in BUN/Creatinine Measurements Creatinine	0.095 mg/dL Standard Deviation 0.24	.04 mg/dL Standard Deviation .03

SECONDARY outcome

Timeframe: baseline and 12 months

Population: Results only available for participants with data for both timepoints.

LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline

Outcome measures

Measure	Renal Sympathetic Denervation n=4 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=1 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Change in LV Size	-.125 cm Standard Deviation .59	-1.4 cm Standard Deviation NA data for N=1

SECONDARY outcome

Timeframe: 24 months

Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction.

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Procedure-related Adverse Events	3 events	3 events

SECONDARY outcome

Timeframe: baseline and 24 months

Population: Results only available for participants with data for both timepoints.

Change in mean arterial pressure

Outcome measures

Measure	Renal Sympathetic Denervation n=6 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=5 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Changes in Mean Arterial Pressure	3.33 mmHg Standard Deviation 8.41	13.77 mmHg Standard Deviation 18.75

SECONDARY outcome

Timeframe: 24 months

Number of participants with other individual complication rates specifically orthostatic hypertension

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Participants With Orthostatic Hypertension	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at 24 months

Other individual complication rates including, but not limited to MI and death

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Participants With Other Complications	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

30-day Major Complication Rate defined as death, stroke, MI or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer)

Outcome measures

Measure	Renal Sympathetic Denervation n=8 Participants Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Number of Occurrences of Major Complication Rate	2 occurrences	3 occurrences

SECONDARY outcome

Timeframe: during procedure

Population: Results only for those participants who underwent renal sympathetic denervation

Renal Denervation Procedure time

Outcome measures

Measure	Renal Sympathetic Denervation Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=9 Participants VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Procedure Time	—	27.83 minutes Standard Deviation 8.8

Adverse Events

Renal Sympathetic Denervation

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

VT Ablation Alone

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Renal Sympathetic Denervation n=9 participants at risk Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=8 participants at risk No further therapy in addition to VT ablation VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Cardiac disorders VT recurrence	0.00% 0/9 • 24 months	25.0% 2/8 • 24 months
Cardiac disorders Non-sustained VT	0.00% 0/9 • 24 months	12.5% 1/8 • 24 months
Infections and infestations Pneumonia	0.00% 0/9 • 24 months	12.5% 1/8 • 24 months
Renal and urinary disorders Macrohematuria	0.00% 0/9 • 24 months	12.5% 1/8 • 24 months
General disorders AF with urosepsis	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Cardiac disorders Worsening heart failure/Total artifical heart implant	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Cardiac disorders Pseudoaneurysm at septal aspect of LV apex	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months

Other adverse events

Measure	Renal Sympathetic Denervation n=9 participants at risk Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).	VT Ablation Alone n=8 participants at risk No further therapy in addition to VT ablation VT ablation alone: Placebo arm will receive standard VT ablation using current techniques
Cardiac disorders VT recurrence	0.00% 0/9 • 24 months	25.0% 2/8 • 24 months
Cardiac disorders Dissection of left external iliac artery	0.00% 0/9 • 24 months	12.5% 1/8 • 24 months
Skin and subcutaneous tissue disorders Paresthesia	0.00% 0/9 • 24 months	12.5% 1/8 • 24 months
Vascular disorders LUE Cephalic vein thrombosis	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Cardiac disorders Hypotension with pleuritic chest pain	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Hepatobiliary disorders Kidney pain with near syncope	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Infections and infestations Flu	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Cardiac disorders Bradycardia associated with dyspnea on exertion	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months
Musculoskeletal and connective tissue disorders Jaw pain	11.1% 1/9 • 24 months	0.00% 0/8 • 24 months

Additional Information

Betsy Ellsworth, Research Program Director

Icahn School of Medicine at Mo

Phone: 212 824 8902

Email: betsy.ellsworth@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place