Trial Outcomes & Findings for REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (NCT NCT01747837)
NCT ID: NCT01747837
Last Updated: 2020-03-04
Results Overview
The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
24 months
Results posted on
2020-03-04
Participant Flow
First enrollment on Oct 22, 2015. Last enrollment on May 3, 2017 with last study visit date conducted on Jan 9, 2019, 50 participants consented, 2 were found ineligible due to irregular renal anatomy during the angiography and not randomized.
Participant milestones
| Measure |
Standard ICD Implantation Alone
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Standard ICD Implantation Alone
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Death
|
4
|
4
|
Baseline Characteristics
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
Baseline characteristics by cohort
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Time to First Event Requiring ICD Therapy or Incessant VT
|
177.2 days
Standard Deviation 148.65
|
148.66 days
Standard Deviation 148.6
|
SECONDARY outcome
Timeframe: 24 monthsNumber of Occurrences of Appropriate ICD therapy assessed in the full intention-to-treat patient cohort. An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Occurrences of Appropriate ICD Therapy
|
46 Occurences
Standard Deviation 3.78
|
122 Occurences
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: 24 monthsNumber of occurrences of inappropriate shocks. Inappropriate ICD therapy are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Occurrences of Inappropriate ICD Therapy
|
388 Occurrences
Standard Deviation 70.4
|
86 Occurrences
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: cumulative number of hospitalizations
Cumulative number of Hospitalizations for Cardiovascular Causes
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Hospitalizations for Cardiovascular Causes
|
11 hospitalizations
|
9 hospitalizations
|
SECONDARY outcome
Timeframe: 24 monthsCumulative Number of episodes of Total VT burden
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Episodes of Total VT Burden
|
513 Episodes
|
671 Episodes
|
SECONDARY outcome
Timeframe: 24 monthsAll-Cause Mortality
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
All-Cause Mortality
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 monthsThe cumulative number of occurrences of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Occurrence of ICD Storm
|
1 occurences
|
2 occurences
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 months, 24 monthsPopulation: data only available for those participants who returned for respective study visits
Blood Urea Nitrogen (BUN) measurements
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
BUN Measurements
Baseline
|
13.31 mmol/L
Standard Deviation 6.24
|
10.6 mmol/L
Standard Deviation 4.33
|
|
BUN Measurements
6 months
|
12 mmol/L
Standard Deviation 5.77
|
11.71 mmol/L
Standard Deviation 7.45
|
|
BUN Measurements
12 months
|
10.02 mmol/L
Standard Deviation 5.76
|
8.71 mmol/L
Standard Deviation 6.87
|
|
BUN Measurements
24 months
|
9.09 mmol/L
Standard Deviation 3.75
|
8 mmol/L
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 months, 24 monthsPopulation: data only available for those participants who returned for respective study visits
Creatinine measurements
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Creatinine Measurements
Baseline
|
105 µmol/L
Standard Deviation 32.57
|
102 µmol/L
Standard Deviation 20.68
|
|
Creatinine Measurements
6 months
|
108 µmol/L
Standard Deviation 24.6
|
108 µmol/L
Standard Deviation 43.12
|
|
Creatinine Measurements
12 months
|
110 µmol/L
Standard Deviation 35.28
|
104 µmol/L
Standard Deviation 28.6
|
|
Creatinine Measurements
24 months
|
107 µmol/L
Standard Deviation 24.97
|
98 µmol/L
Standard Deviation 14.24
|
SECONDARY outcome
Timeframe: 24 monthsProcedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Procedure Related Adverse Events
|
2 Events
|
7 Events
|
SECONDARY outcome
Timeframe: 24 monthsNumber of participants who developed of orthostatic hypotension
Outcome measures
| Measure |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Participants With Orthostatic Hypotension
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: average 30 daysNumber of Participants with Major Complication defined as death, stroke, myocardial infarction (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 |
Standard ICD Implantation Alone
n=25 Participants
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 Participants
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Number of Participants With Major Complication
|
0 Participants
|
3 Participants
|
Adverse Events
Standard ICD Implantation Alone
Serious events: 10 serious events
Other events: 3 other events
Deaths: 4 deaths
Boston Scientific Vessix Renal Denervation System
Serious events: 11 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Standard ICD Implantation Alone
n=25 participants at risk
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 participants at risk
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Infections and infestations
Bedsore of pocket ICD
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Cardiac disorders
Cardiac Arrhythmias
|
12.0%
3/25 • 24 months
|
8.7%
2/23 • 24 months
|
|
General disorders
Collapse
|
4.0%
1/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema Thoracalgia
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Cardiac disorders
Episode of Chest Pain
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Cardiac disorders
Heart Failure
|
16.0%
4/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Hip Surgery
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Surgical and medical procedures
Implantation of BIV IC
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
General disorders
Ischemic Stroke
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/25 • 24 months
|
8.7%
2/23 • 24 months
|
|
Cardiac disorders
Pleural Effusion
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pocket Hematoma
|
4.0%
1/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Surgical and medical procedures
Pocket Revision
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Infections and infestations
Skin erosion on the place of ICD
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Cardiac disorders
Stable exertional angina
|
4.0%
1/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
General disorders
Syncope
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
Other adverse events
| Measure |
Standard ICD Implantation Alone
n=25 participants at risk
These subjects will undergo standard ICD implantation alone (if not already present)
|
Boston Scientific Vessix Renal Denervation System
n=23 participants at risk
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Infection
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Surgical and medical procedures
Dislocation of the Atrial Electrode
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Skin and subcutaneous tissue disorders
Groin Hematoma
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of Left Kidney
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
|
Cardiac disorders
Puncture
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/25 • 24 months
|
8.7%
2/23 • 24 months
|
|
Cardiac disorders
Cardiac Arrhythmias
|
4.0%
1/25 • 24 months
|
0.00%
0/23 • 24 months
|
|
General disorders
Collapse
|
0.00%
0/25 • 24 months
|
4.3%
1/23 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place