Trial Outcomes & Findings for Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation (NCT NCT01635998)
NCT ID: NCT01635998
Last Updated: 2020-11-05
Results Overview
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
up to 12 months
Results posted on
2020-11-05
Participant Flow
Participant milestones
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
22
|
|
Overall Study
COMPLETED
|
24
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
65.17 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 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
|
0 Participants
n=7 Participants
|
0 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
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 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
|
|
Type of Atrial Fibrillation (AF)
Paroxysmal AF
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Type of Atrial Fibrillation (AF)
Persistent AF
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsThe primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
|
6 recurrences
|
2 recurrences
|
SECONDARY outcome
Timeframe: up to 24 monthsAAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
AAD-free Single-procedure Freedom From AF Recurrence
|
7 recurrences
|
6 recurrences
|
SECONDARY outcome
Timeframe: up to 24 monthsFreedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Freedom From AF Recurrence Despite Taking AADs
|
6 recurrences
|
5 recurrences
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 months, and 24 monthsBlood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Blood Pressure Control as Compared to Baseline
Systolic Baseline
|
146.6 mmHg
Standard Deviation 20.6
|
143.45 mmHg
Standard Deviation 18.47
|
|
Blood Pressure Control as Compared to Baseline
Systolic 6 months
|
136.88 mmHg
Standard Deviation 17.36
|
142.06 mmHg
Standard Deviation 78.94
|
|
Blood Pressure Control as Compared to Baseline
Systolic 12 months
|
137.88 mmHg
Standard Deviation 17.55
|
144.53 mmHg
Standard Deviation 21.6
|
|
Blood Pressure Control as Compared to Baseline
Systolic 24 months
|
133.88 mmHg
Standard Deviation 14.4
|
138.7 mmHg
Standard Deviation 19.9
|
|
Blood Pressure Control as Compared to Baseline
Diastolic Baseline
|
81.46 mmHg
Standard Deviation 13.4
|
79.18 mmHg
Standard Deviation 12.45
|
|
Blood Pressure Control as Compared to Baseline
Diastolic 6 months
|
80.88 mmHg
Standard Deviation 10.08
|
78.94 mmHg
Standard Deviation 7.8
|
|
Blood Pressure Control as Compared to Baseline
Diastolic 12 months
|
82.36 mmHg
Standard Deviation 9.19
|
82.03 mmHg
Standard Deviation 6.6
|
|
Blood Pressure Control as Compared to Baseline
Diastolic 24 months
|
79.8 mmHg
Standard Deviation 7.48
|
78.87 mmHg
Standard Deviation 9.75
|
SECONDARY outcome
Timeframe: within 12 months of randomizationNumber of Participants with Major adverse cardiac events (MACE) defined as a non-weighted composite score of: death, stroke, CHF hospitalization, and clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsSAE-any experience that results in a fatality or is life threatening; results in significant or persistent disability; requires or prolongs hospitalization; results in congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators. Important medical events that may not result in above may be considered a SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at baseline and at 12 monthsLA size by TTE at baseline and at 12 months
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Left Atrial (LA) Size
Baseline
|
5.4 cm
Standard Deviation 0.8
|
4.7 cm
Standard Deviation 1.3
|
|
Left Atrial (LA) Size
12 months
|
5.19 cm
Standard Deviation 0.9
|
4.68 cm
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: at baseline and at 12 monthsEjection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. A normal heart's ejection fraction may be between 50 and 70 percent.
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Ejection Fraction (EF)
Baseline
|
62.52 percent of blood
Standard Deviation 6.88
|
63.84 percent of blood
Standard Deviation 6.25
|
|
Ejection Fraction (EF)
12 months
|
62.9 percent of blood
Standard Deviation 7.21
|
64.5 percent of blood
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: up to 24 monthsCausality will be defined as adverse events that, after careful medical evaluation, are considered with a high degree of certainty to be related to the intervention (AF ablation ± renal sympathetic denervation).
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Number of Participants With Procedure Adverse Events
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline and 24 monthsTotal number of anti-hypertensive medications at study end, compared between the two treatment arms
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Number of Anti-hypertensive Medications
Baseline
|
2.8 medications
Standard Deviation 0.95
|
2.5 medications
Standard Deviation 1.0
|
|
Number of Anti-hypertensive Medications
24 months
|
2.8 medications
Standard Deviation 1.0
|
2.35 medications
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline, 12 months and 24 monthsThe change in quality of life (QoL) from baseline to 12 months as measured by AFEQT, a 20- item instrument. Full range from 0 to 100, with higher score indicates higher level of QoL.
Outcome measures
| Measure |
Renal Sympathetic Denervation PLUS Catheter Ablation
n=28 Participants
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 Participants
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
12 months
|
37.95 score on a scale
Standard Deviation 16.13
|
30 score on a scale
Standard Deviation 11.58
|
|
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
Baseline
|
72.75 score on a scale
Standard Deviation 22.85
|
75.4 score on a scale
Standard Deviation 26.54
|
|
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
24 months
|
39.8 score on a scale
Standard Deviation 20.32
|
36.57 score on a scale
Standard Deviation 21.1
|
Adverse Events
Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti
Serious events: 12 serious events
Other events: 6 other events
Deaths: 1 deaths
Routine Catheter Abation
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti
n=28 participants at risk
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 participants at risk
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Congenital, familial and genetic disorders
Cardiac Arrhythmia
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Renal and urinary disorders
Enlarged Prostate
|
0.00%
0/28 • 24 months
|
4.5%
1/22 • 24 months
|
|
Gastrointestinal disorders
Esophageal Ulcer
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Vascular disorders
Femoral Pseudoaneurysm
|
10.7%
3/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Immune system disorders
Fever
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Immune system disorders
Neutropenic fever
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
General disorders
Pulmonary Edema
|
0.00%
0/28 • 24 months
|
4.5%
1/22 • 24 months
|
|
Renal and urinary disorders
Renal Dysfunction
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/28 • 24 months
|
9.1%
2/22 • 24 months
|
Other adverse events
| Measure |
Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti
n=28 participants at risk
Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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.
|
Routine Catheter Abation
n=22 participants at risk
Routine catheter ablation of atrial fibrillation only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Cardiac disorders
Aortic Aneurysm Dissection
|
0.00%
0/28 • 24 months
|
4.5%
1/22 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Atypical Chest Pain
|
0.00%
0/28 • 24 months
|
4.5%
1/22 • 24 months
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/28 • 24 months
|
9.1%
2/22 • 24 months
|
|
Eye disorders
Blurred vision
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Skin and subcutaneous tissue disorders
Groin Hematoma
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Gastrointestinal disorders
Hemoptysis
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/28 • 24 months
|
4.5%
1/22 • 24 months
|
|
General disorders
Syncope
|
3.6%
1/28 • 24 months
|
0.00%
0/22 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place