Trial Outcomes & Findings for A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence (NCT NCT01907828)
NCT ID: NCT01907828
Last Updated: 2020-05-22
Results Overview
The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
12 months
Results posted on
2020-05-22
Participant Flow
Study enrollment was completed with a total of 61 participants randomized at 2 sites in Germany. The first and last participants were enrolled on May 12, 2014, and July 21, 2016, respectively.
Participant milestones
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
22
|
|
Overall Study
Underwent Procedure
|
39
|
20
|
|
Overall Study
1-month Follow-up
|
37
|
17
|
|
Overall Study
3-month Follow-up
|
36
|
16
|
|
Overall Study
6-month Follow-up
|
35
|
16
|
|
Overall Study
12-month Follow-up
|
34
|
16
|
|
Overall Study
24-month Follow-up
|
32
|
16
|
|
Overall Study
COMPLETED
|
32
|
16
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Overall Study
Exclusion criteria not met
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Participant refused 24-month follow-up
|
1
|
0
|
|
Overall Study
Participant met exclusion criteria
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=22 Participants
Participants treated with cardiac ablation alone.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 7.9 • n=39 Participants
|
63.0 years
STANDARD_DEVIATION 9.9 • n=22 Participants
|
65.1 years
STANDARD_DEVIATION 8.7 • n=61 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
10 Participants
n=22 Participants
|
29 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=39 Participants
|
12 Participants
n=22 Participants
|
32 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
39 Participants
n=39 Participants
|
22 Participants
n=22 Participants
|
61 Participants
n=61 Participants
|
|
Height
|
172.7 cm
STANDARD_DEVIATION 10.1 • n=39 Participants
|
173.6 cm
STANDARD_DEVIATION 9.4 • n=22 Participants
|
173.0 cm
STANDARD_DEVIATION 9.8 • n=61 Participants
|
|
Weight
|
95.4 kg
STANDARD_DEVIATION 17.9 • n=39 Participants
|
93.7 kg
STANDARD_DEVIATION 19.1 • n=22 Participants
|
94.8 kg
STANDARD_DEVIATION 18.2 • n=61 Participants
|
|
Body mass Index (BMI)
|
31.9 kg/m^2
STANDARD_DEVIATION 5.0 • n=39 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 5.4 • n=22 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 5.1 • n=61 Participants
|
|
Office Blood Pressure
Office Systolic Blood Pressure
|
162.0 mmHg
STANDARD_DEVIATION 18.6 • n=39 Participants
|
167.1 mmHg
STANDARD_DEVIATION 18.5 • n=22 Participants
|
163.9 mmHg
STANDARD_DEVIATION 18.5 • n=61 Participants
|
|
Office Blood Pressure
Office Diastolic Blood Pressure
|
87.5 mmHg
STANDARD_DEVIATION 14.1 • n=39 Participants
|
91.4 mmHg
STANDARD_DEVIATION 10.6 • n=22 Participants
|
88.9 mmHg
STANDARD_DEVIATION 13.0 • n=61 Participants
|
|
Office Heart Rate
|
81.3 beats per minute (bpm)
STANDARD_DEVIATION 23.9 • n=39 Participants
|
76.7 beats per minute (bpm)
STANDARD_DEVIATION 19.5 • n=22 Participants
|
79.7 beats per minute (bpm)
STANDARD_DEVIATION 22.4 • n=61 Participants
|
|
Number of Participants with a history of renal assessment prior to enrollment
|
2 Participants
n=39 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=61 Participants
|
|
New York Heart Association (NYHA) Class of Cardiac Disease
Class I
|
10 Participants
n=39 Participants
|
11 Participants
n=22 Participants
|
21 Participants
n=61 Participants
|
|
New York Heart Association (NYHA) Class of Cardiac Disease
Class II
|
24 Participants
n=39 Participants
|
10 Participants
n=22 Participants
|
34 Participants
n=61 Participants
|
|
New York Heart Association (NYHA) Class of Cardiac Disease
Class III
|
5 Participants
n=39 Participants
|
1 Participants
n=22 Participants
|
6 Participants
n=61 Participants
|
|
New York Heart Association (NYHA) Class of Cardiac Disease
Class IV
|
0 Participants
n=39 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=61 Participants
|
|
Medical History
Myocardial Infarction
|
1 Participants
n=39 Participants
|
3 Participants
n=22 Participants
|
4 Participants
n=61 Participants
|
|
Medical History
Coronary Artery Disease
|
5 Participants
n=39 Participants
|
7 Participants
n=22 Participants
|
12 Participants
n=61 Participants
|
|
Medical History
Valvular Disease
|
27 Participants
n=39 Participants
|
15 Participants
n=22 Participants
|
42 Participants
n=61 Participants
|
|
Medical History
Arrhythmia
|
39 Participants
n=39 Participants
|
22 Participants
n=22 Participants
|
61 Participants
n=61 Participants
|
|
Medical History
Cardiomyopathy
|
2 Participants
n=39 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=61 Participants
|
|
Medical History
Neurological events/Dysfunction
|
2 Participants
n=39 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=61 Participants
|
|
Medical History
Hyperlipidemia
|
20 Participants
n=39 Participants
|
11 Participants
n=22 Participants
|
31 Participants
n=61 Participants
|
|
Medical History
Diabetes
|
16 Participants
n=39 Participants
|
7 Participants
n=22 Participants
|
23 Participants
n=61 Participants
|
|
Medical History
Smokers
|
17 Participants
n=39 Participants
|
4 Participants
n=22 Participants
|
21 Participants
n=61 Participants
|
|
Medical History
Significant Alcohol Intake
|
6 Participants
n=39 Participants
|
0 Participants
n=22 Participants
|
6 Participants
n=61 Participants
|
|
Medical History
Obstructive Sleep Apnea
|
3 Participants
n=39 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=61 Participants
|
|
Medical History
Thyroid Disease
|
8 Participants
n=39 Participants
|
6 Participants
n=22 Participants
|
14 Participants
n=61 Participants
|
|
Medical History
Liver Disease
|
2 Participants
n=39 Participants
|
4 Participants
n=22 Participants
|
6 Participants
n=61 Participants
|
|
Medical History
Other Additional Medical History
|
38 Participants
n=39 Participants
|
18 Participants
n=22 Participants
|
56 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data not collected from all participants: data were available for only 28 participants in the RDN+AF group, and 12 participants in the AF group
The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=28 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=12 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Number of Participants With Freedom From Atrial Fibrillation at 12 Month
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 7 days, 6 months, 12 months, and 24 months post procedurePopulation: For each group, the outcome measure was analyzed in participants randomized at baseline
Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22).
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=22 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Major Adverse Cardiac Events (MACE)
MACE within 7 days of procedure
|
0 Participants
|
2 Participants
|
|
Major Adverse Cardiac Events (MACE)
MACE within 6 months of procedure
|
0 Participants
|
2 Participants
|
|
Major Adverse Cardiac Events (MACE)
MACE within 12 months of procedure
|
0 Participants
|
2 Participants
|
|
Major Adverse Cardiac Events (MACE)
MACE within 24 months of procedure
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days post procedurePopulation: Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=22 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Percentage of Participants Who Experience Peri-procedural Events
Bleeding
|
0 Participants
|
1 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
VASC Pseudoaneurysm
|
1 Participants
|
0 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Air Embolus
|
3 Participants
|
0 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Paroxysmal Atrial Fibrillation
|
1 Participants
|
0 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Vasospasm
|
1 Participants
|
0 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Cardiac Arrest
|
0 Participants
|
1 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Pericardial Effusion
|
0 Participants
|
1 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Paroxysmal Atrial Tachycardia
|
1 Participants
|
0 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Hematoma
|
0 Participants
|
1 Participants
|
|
Percentage of Participants Who Experience Peri-procedural Events
Pericardial Tamponade
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 months post procedurePopulation: Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=22 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
VASC Pseudoaneurysm at 6 months
|
1 Participants
|
0 Participants
|
|
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
VASC Pseudoaneurysm at 12 months
|
2 Participants
|
0 Participants
|
|
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
Renal Artery Stenosis at 6 months
|
0 Participants
|
0 Participants
|
|
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
Renal Artery Stenosis at 12 months
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 32)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=32 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months
|
2.2 mL/min per 1.73m^2
Standard Deviation 11.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 33)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=33 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months
|
-0.4 mL/min per 1.73m^2
Standard Deviation 11.9
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months, 24 monthsPopulation: For each group, the outcome measure was analyzed in participants who underwent the procedure (RDN+AF group= 39, AF group=20)
Recurrence of AF was summarized as a percentage based on the number of subjects who underwent the procedure (RDN+AF group= 39, AF group=20)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=20 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Atrial Fibrillation recurrence within 12 months
|
14 Participants
|
8 Participants
|
|
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Atrial Fibrillation recurrence within 24 months
|
19 Participants
|
9 Participants
|
|
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Atrial Fibrillation recurrence within 3 months
|
4 Participants
|
4 Participants
|
|
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Atrial Fibrillation recurrence within 6 months
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months post procedureOutcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=35 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=16 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 months post procedurePopulation: Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=22 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=14 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Change in Ambulatory Blood Pressure at 12 Months
24-Hour Ambulatory Systolic Blood Pressure (ASBP)
|
-5.9 mmHg
Standard Deviation 15.2
|
-3.1 mmHg
Standard Deviation 19.2
|
|
Change in Ambulatory Blood Pressure at 12 Months
24-Hour Ambulatory Diastolic Blood Pressure (ADBP)
|
-5.8 mmHg
Standard Deviation 7.4
|
-8.4 mmHg
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline and 24 months post procedurePopulation: Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=17 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=12 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Change in Ambulatory Blood Pressure at 24 Months
24-Hour Ambulatory Systolic Blood Pressure (ASBP)
|
-5.7 mmHg
Standard Deviation 14.8
|
-8.6 mmHg
Standard Deviation 12.4
|
|
Change in Ambulatory Blood Pressure at 24 Months
24-Hour Ambulatory Diastolic Blood Pressure (ADBP)
|
-6.9 mmHg
Standard Deviation 6.1
|
-10.3 mmHg
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline and 12 months post procedurePopulation: Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=33 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=15 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Change in Office Blood Pressure at 12 Months
Change in Office Systolic Blood Pressure (OSBP)
|
2.6 mmHg
Standard Deviation 24.4
|
2.0 mmHg
Standard Deviation 30.0
|
|
Change in Office Blood Pressure at 12 Months
Change in Office Diastolic Blood Pressure (ODBP)
|
-0.4 mmHg
Standard Deviation 11.8
|
-5.4 mmHg
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Baseline and 24 months post procedurePopulation: Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Outcome measures
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=29 Participants
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=16 Participants
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Change in Office Blood Pressure at 24 Months
Change in Office Systolic Blood Pressure (OSBP)
|
0.6 mmHg
Standard Deviation 22.3
|
7.4 mmHg
Standard Deviation 22.9
|
|
Change in Office Blood Pressure at 24 Months
Change in Office Diastolic Blood Pressure (ODBP)
|
0.5 mmHg
Standard Deviation 11.0
|
-3.0 mmHg
Standard Deviation 15.5
|
Adverse Events
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Cardiac Ablation (AF)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 participants at risk
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=22 participants at risk
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Cardiac disorders
Paroxysmal Atrial Tachycardia
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
|
Cardiac disorders
Paroxysmal Atrial Fibrillation
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/39 • 24 months
|
4.5%
1/22 • Number of events 1 • 24 months
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/39 • 24 months
|
4.5%
1/22 • Number of events 1 • 24 months
|
|
Cardiac disorders
Pericardial Tamponade
|
0.00%
0/39 • 24 months
|
4.5%
1/22 • Number of events 1 • 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
|
Vascular disorders
VASC Pseudoaneurysm
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
|
Vascular disorders
Renal Artery Stenosis
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
Other adverse events
| Measure |
Renal Artery Ablation + Cardiac Ablation (RDN+AF)
n=39 participants at risk
Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
|
Cardiac Ablation (AF)
n=22 participants at risk
Participants treated with cardiac ablation alone.
|
|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/39 • 24 months
|
4.5%
1/22 • Number of events 1 • 24 months
|
|
Vascular disorders
Bleeding
|
0.00%
0/39 • 24 months
|
4.5%
1/22 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Air Embolus
|
7.7%
3/39 • Number of events 3 • 24 months
|
0.00%
0/22 • 24 months
|
|
Vascular disorders
Vasospasm
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
|
Vascular disorders
VASC Pseudoaneurysm
|
2.6%
1/39 • Number of events 1 • 24 months
|
0.00%
0/22 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER