RDN+AF: A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01907828
Collaborator
(none)
61
2
2
54
30.5
0.6
Study Details
Study Description
Brief Summary
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being treated for Atrial Fibrillation
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a post market, prospective, multicenter, 2:1 randomized study of the EnligHTN™ Renal Denervation System in conjunction with atrial fibrillation ablation. Up to one hundred subjects with paroxysmal or persistent atrial fibrillation and uncontrolled hypertension will be enrolled in the study. All subjects will undergo cardiac ablation for the treatment of atrial fibrillation. Per the 2:1 randomization, a minimum of 50 or 2/3 of the total patient cohort will also undergo renal artery ablation. Subjects will be followed up to years (2) years post procedure.
Study Design
Study Type:
Interventional
Actual Enrollment
:
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Actual Study Start Date
:
Apr 15, 2014
Actual Primary Completion Date
:
Oct 15, 2018
Actual Study Completion Date
:
Oct 15, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cardiac ablation + renal artery ablation Renal artery ablation with the EnligHTN™ Renal Denervation System |
Device: Renal Artery Ablation
Renal artery denervation using the EnligHTN™ Renal Denervation System
Device: Cardiac Ablation
Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer
|
| Active Comparator: Cardiac ablation Cardiac ablation |
Device: Cardiac Ablation
Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Freedom From Atrial Fibrillation at 12 Month [12 months]
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).
Secondary Outcome Measures
- Major Adverse Cardiac Events (MACE) [7 days, 6 months, 12 months, and 24 months post procedure]
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).
- Percentage of Participants Who Experience Peri-procedural Events [30 days post procedure]
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)
- Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation [6 months and 12 months post procedure]
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).
- Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months [Baseline and 6 months]
- Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months [Baseline and 12 months]
- Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. [3 months, 6 months, 12 months, 24 months]
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)
- Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg [6 months post procedure]
- Change in Ambulatory Blood Pressure at 12 Months [Baseline and 12 months post procedure]
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 at 24 Months [Baseline and 24 months post procedure]
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 Office Blood Pressure at 12 Months [Baseline and 12 months post procedure]
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 at 24 Months [Baseline and 24 months post procedure]
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is ≥ 18 years of age at time of consent
-
Subject must be able and willing to provide written informed consent
-
Subject must be able and willing to comply with the required follow-up schedule
-
Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care
-
Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit
-
Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
-
Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is taking >3 anti-hypertensive medications, including 1 diuretic
-
Subject has been on a stable unchanged anti-hypertensive medication regimen for a minimum of 4 weeks prior to the ablation procedure
Exclusion Criteria:
-
Subject has long standing atrial fibrillation
-
Subject has had a previous ablation for atrial fibrillation
-
Subject has had a previous renal denervation procedure
-
Subject has had a CABG procedure within the last 180 days (six months)
-
Subject has a left atrial thrombus
-
Subject has a contraindication to anticoagulation (i.e. heparin or warfarin)
-
Subject has unstable angina
-
Subject has had a myocardial infarction within the previous two months
-
Subject has a left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure TTE
-
Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
-
Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
-
Subject has hemodynamically significant valvular heart disease as determined by study investigator
-
Subject has a life expectancy less than 12 months, as determined by the study investigator
-
Subject is participating in another clinical study which has the potential to impact his/her hypertension or atrial fibrillation management (pharmaceutical/device/homeopathic)
-
Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
-
Subject has active systemic infection
-
Subject has renal arteries < 4 mm in diameter
-
Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
-
Subject had a renal transplant or is awaiting a renal transplant
-
Subject has blood clotting or bleeding abnormalities
-
Subject has secondary arterial hypertension
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herzzentrum Dresden GmbH Universitätsklinik | Dresden | Germany | 01307 | |
| 2 | Herzzentrum Leipzig GmbH | Leipzig | Germany | 04289 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Christopher Piorkowski, MD, Herzzentrum Dresden GmbH Universitätsklinik
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01907828
Other Study ID Numbers:
- SJM-CIP-0009
First Posted:
Jul 25, 2013
Last Update Posted:
May 22, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Period Title: Overall Study | ||
| STARTED | 39 | 22 |
| Underwent Procedure | 39 | 20 |
| 1-month Follow-up | 37 | 17 |
| 3-month Follow-up | 36 | 16 |
| 6-month Follow-up | 35 | 16 |
| 12-month Follow-up | 34 | 16 |
| 24-month Follow-up | 32 | 16 |
| COMPLETED | 32 | 16 |
| NOT COMPLETED | 7 | 6 |
Baseline Characteristics
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) | Total |
|---|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. | Total of all reporting groups |
| Overall Participants | 39 | 22 | 61 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.3
(7.9)
|
63.0
(9.9)
|
65.1
(8.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
19
48.7%
|
10
45.5%
|
29
47.5%
|
| Male |
20
51.3%
|
12
54.5%
|
32
52.5%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (Count of Participants) | |||
| Germany |
39
100%
|
22
100%
|
61
100%
|
| Height (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
172.7
(10.1)
|
173.6
(9.4)
|
173.0
(9.8)
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
95.4
(17.9)
|
93.7
(19.1)
|
94.8
(18.2)
|
| Body mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
31.9
(5.0)
|
31.0
(5.4)
|
31.6
(5.1)
|
| Office Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Office Systolic Blood Pressure |
162.0
(18.6)
|
167.1
(18.5)
|
163.9
(18.5)
|
| Office Diastolic Blood Pressure |
87.5
(14.1)
|
91.4
(10.6)
|
88.9
(13.0)
|
| Office Heart Rate (beats per minute (bpm)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [beats per minute (bpm)] |
81.3
(23.9)
|
76.7
(19.5)
|
79.7
(22.4)
|
| Number of Participants with a history of renal assessment prior to enrollment (Count of Participants) | |||
| Count of Participants [Participants] |
2
5.1%
|
0
0%
|
2
3.3%
|
| New York Heart Association (NYHA) Class of Cardiac Disease (Count of Participants) | |||
| Class I |
10
25.6%
|
11
50%
|
21
34.4%
|
| Class II |
24
61.5%
|
10
45.5%
|
34
55.7%
|
| Class III |
5
12.8%
|
1
4.5%
|
6
9.8%
|
| Class IV |
0
0%
|
0
0%
|
0
0%
|
| Medical History (Count of Participants) | |||
| Myocardial Infarction |
1
2.6%
|
3
13.6%
|
4
6.6%
|
| Coronary Artery Disease |
5
12.8%
|
7
31.8%
|
12
19.7%
|
| Valvular Disease |
27
69.2%
|
15
68.2%
|
42
68.9%
|
| Arrhythmia |
39
100%
|
22
100%
|
61
100%
|
| Cardiomyopathy |
2
5.1%
|
1
4.5%
|
3
4.9%
|
| Neurological events/Dysfunction |
2
5.1%
|
2
9.1%
|
4
6.6%
|
| Hyperlipidemia |
20
51.3%
|
11
50%
|
31
50.8%
|
| Diabetes |
16
41%
|
7
31.8%
|
23
37.7%
|
| Smokers |
17
43.6%
|
4
18.2%
|
21
34.4%
|
| Significant Alcohol Intake |
6
15.4%
|
0
0%
|
6
9.8%
|
| Obstructive Sleep Apnea |
3
7.7%
|
1
4.5%
|
4
6.6%
|
| Thyroid Disease |
8
20.5%
|
6
27.3%
|
14
23%
|
| Liver Disease |
2
5.1%
|
4
18.2%
|
6
9.8%
|
| Other Additional Medical History |
38
97.4%
|
18
81.8%
|
56
91.8%
|
Outcome Measures
| Title | Number of Participants With Freedom From Atrial Fibrillation at 12 Month |
|---|---|
| Description | 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). |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 28 | 12 |
| Count of Participants [Participants] |
16
41%
|
4
18.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF), Cardiac Ablation (AF) |
|---|---|---|
| Comments | Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Major Adverse Cardiac Events (MACE) |
|---|---|
| Description | 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). |
| Time Frame | 7 days, 6 months, 12 months, and 24 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| For each group, the outcome measure was analyzed in participants randomized at baseline |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 39 | 22 |
| MACE within 7 days of procedure |
0
0%
|
2
9.1%
|
| MACE within 6 months of procedure |
0
0%
|
2
9.1%
|
| MACE within 12 months of procedure |
0
0%
|
2
9.1%
|
| MACE within 24 months of procedure |
0
0%
|
2
9.1%
|
| Title | Percentage of Participants Who Experience Peri-procedural Events |
|---|---|
| Description | 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) |
| Time Frame | 30 days post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 39 | 22 |
| Cardiac Arrest |
0
0%
|
1
4.5%
|
| Pericardial Effusion |
0
0%
|
1
4.5%
|
| Paroxysmal Atrial Tachycardia |
1
2.6%
|
0
0%
|
| Hematoma |
0
0%
|
1
4.5%
|
| Pericardial Tamponade |
0
0%
|
1
4.5%
|
| Bleeding |
0
0%
|
1
4.5%
|
| VASC Pseudoaneurysm |
1
2.6%
|
0
0%
|
| Air Embolus |
3
7.7%
|
0
0%
|
| Paroxysmal Atrial Fibrillation |
1
2.6%
|
0
0%
|
| Vasospasm |
1
2.6%
|
0
0%
|
| Title | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation |
|---|---|
| Description | 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). |
| Time Frame | 6 months and 12 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 39 | 22 |
| VASC Pseudoaneurysm at 6 months |
1
2.6%
|
0
0%
|
| VASC Pseudoaneurysm at 12 months |
2
5.1%
|
0
0%
|
| Renal Artery Stenosis at 6 months |
0
0%
|
0
0%
|
| Renal Artery Stenosis at 12 months |
1
2.6%
|
0
0%
|
| Title | Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months |
|---|---|
| Description | |
| Time Frame | Baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 32) |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. |
| Measure Participants | 32 |
| Mean (Standard Deviation) [mL/min per 1.73m^2] |
2.2
(11.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2766 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Title | Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months |
|---|---|
| Description | |
| Time Frame | Baseline and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 33) |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. |
| Measure Participants | 33 |
| Mean (Standard Deviation) [mL/min per 1.73m^2] |
-0.4
(11.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7663 |
| Comments | ||
| Method | Wilcoxon signed-rank test | |
| Comments | ||
| Title | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. |
|---|---|
| Description | 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) |
| Time Frame | 3 months, 6 months, 12 months, 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| For each group, the outcome measure was analyzed in participants who underwent the procedure (RDN+AF group= 39, AF group=20) |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 39 | 20 |
| Atrial Fibrillation recurrence within 3 months |
4
10.3%
|
4
18.2%
|
| Atrial Fibrillation recurrence within 6 months |
9
23.1%
|
5
22.7%
|
| Atrial Fibrillation recurrence within 12 months |
14
35.9%
|
8
36.4%
|
| Atrial Fibrillation recurrence within 24 months |
19
48.7%
|
9
40.9%
|
| Title | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg |
|---|---|
| Description | |
| Time Frame | 6 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 35 | 16 |
| Count of Participants [Participants] |
4
10.3%
|
1
4.5%
|
| Title | Change in Ambulatory Blood Pressure at 12 Months |
|---|---|
| Description | Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14) |
| Time Frame | Baseline and 12 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14) |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 22 | 14 |
| 24-Hour Ambulatory Systolic Blood Pressure (ASBP) |
-5.9
(15.2)
|
-3.1
(19.2)
|
| 24-Hour Ambulatory Diastolic Blood Pressure (ADBP) |
-5.8
(7.4)
|
-8.4
(9.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in ASBP at 12 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0849 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.86 | |
| Confidence Interval |
(2-Sided) 95% -12.61 to 0.88 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 15.21 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in ADBP at 12 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0014 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.82 | |
| Confidence Interval |
(2-Sided) 95% -9.12 to -2.52 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 7.45 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in ASBP at 12 months. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5599 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.07 | |
| Confidence Interval |
(2-Sided) 95% -14.16 to 8.02 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 19.21 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in ADBP at 12 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0052 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -8.43 | |
| Confidence Interval |
(2-Sided) 95% -13.87 to -2.99 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 9.42 |
|
| Estimation Comments | ||
| Title | Change in Ambulatory Blood Pressure at 24 Months |
|---|---|
| Description | Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12) |
| Time Frame | Baseline and 24 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12) |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 17 | 12 |
| 24-Hour Ambulatory Systolic Blood Pressure (ASBP) |
-5.7
(14.8)
|
-8.6
(12.4)
|
| 24-Hour Ambulatory Diastolic Blood Pressure (ADBP) |
-6.9
(6.1)
|
-10.3
(8.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in ASBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1326 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.71 | |
| Confidence Interval |
(2-Sided) 95% -13.34 to 1.93 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 14.84 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in ADBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.94 | |
| Confidence Interval |
(2-Sided) 95% -10.06 to -3.83 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 6.06 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in ASBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0354 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -8.58 | |
| Confidence Interval |
(2-Sided) 95% -16.47 to -0.70 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 12.41 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in ADBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -10.33 | |
| Confidence Interval |
(2-Sided) 95% -15.75 to -4.91 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 8.53 |
|
| Estimation Comments | ||
| Title | Change in Office Blood Pressure at 12 Months |
|---|---|
| Description | Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15) |
| Time Frame | Baseline and 12 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15) |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 33 | 15 |
| Change in Office Systolic Blood Pressure (OSBP) |
2.6
(24.4)
|
2.0
(30.0)
|
| Change in Office Diastolic Blood Pressure (ODBP) |
-0.4
(11.8)
|
-5.4
(15.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in OSBP at 12 months. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5399 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.6 | |
| Confidence Interval |
(2-Sided) 95% -6.0 to 11.3 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 24.4 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in Office Diastolic Blood Pressure (ODBP) at 12 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8489 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.4 | |
| Confidence Interval |
(2-Sided) 95% -4.6 to 3.8 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 11.8 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Change in Office Systolic Blood Pressure (OSBP) at 12 months. | |
| Statistical Test of Hypothesis | p-Value | 0.7999 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.0 | |
| Confidence Interval |
(2-Sided) 95% -14.6 to 18.6 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 30.0 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in ODBP at 12 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2076 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.4 | |
| Confidence Interval |
(2-Sided) 95% -14.2 to 3.4 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 15.8 |
|
| Estimation Comments | ||
| Title | Change in Office Blood Pressure at 24 Months |
|---|---|
| Description | Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16). |
| Time Frame | Baseline and 24 months post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16). |
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) |
|---|---|---|
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. |
| Measure Participants | 29 | 16 |
| Change in Office Systolic Blood Pressure (OSBP) |
0.6
(22.3)
|
7.4
(22.9)
|
| Change in Office Diastolic Blood Pressure (ODBP) |
0.5
(11.0)
|
-3.0
(15.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in OSBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8820 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% -7.9 to 9.1 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 22.3 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|
| Comments | Change in ODBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8019 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.5 | |
| Confidence Interval |
(2-Sided) 95% -3.7 to 4.7 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 11.0 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in OSBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2177 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.4 | |
| Confidence Interval |
(2-Sided) 95% -4.8 to 19.6 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 22.9 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cardiac Ablation (AF) |
|---|---|---|
| Comments | Change in ODBP at 24 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4502 |
| Comments | ||
| Method | Paired Student's t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.0 | |
| Confidence Interval |
(2-Sided) 95% -11.2 to 5.2 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 15.5 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 24 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) | ||
| Arm/Group Description | Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | Participants treated with cardiac ablation alone. | ||
All Cause Mortality |
||||
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/39 (0%) | 0/22 (0%) | ||
Serious Adverse Events |
||||
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/39 (10.3%) | 3/22 (13.6%) | ||
| Cardiac disorders | ||||
| Paroxysmal Atrial Tachycardia | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
| Paroxysmal Atrial Fibrillation | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
| Cardiac Arrest | 0/39 (0%) | 0 | 1/22 (4.5%) | 1 |
| Pericardial Effusion | 0/39 (0%) | 0 | 1/22 (4.5%) | 1 |
| Pericardial Tamponade | 0/39 (0%) | 0 | 1/22 (4.5%) | 1 |
| Endocrine disorders | ||||
| Hyperthyroidism | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
| Vascular disorders | ||||
| VASC Pseudoaneurysm | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
| Renal Artery Stenosis | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Cardiac Ablation (AF) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/39 (10.3%) | 2/22 (9.1%) | ||
| Endocrine disorders | ||||
| Hyperthyroidism | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Air Embolus | 3/39 (7.7%) | 3 | 0/22 (0%) | 0 |
| Vascular disorders | ||||
| Hematoma | 0/39 (0%) | 0 | 1/22 (4.5%) | 1 |
| Bleeding | 0/39 (0%) | 0 | 1/22 (4.5%) | 1 |
| Vasospasm | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
| VASC Pseudoaneurysm | 1/39 (2.6%) | 1 | 0/22 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Rebecca Maslow, MA, Clinical Project Manager |
|---|---|
| Organization | Abbott |
| Phone | +1 651-756-5564 |
| rebecca.maslow@abbott.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01907828
Other Study ID Numbers:
- SJM-CIP-0009
First Posted:
Jul 25, 2013
Last Update Posted:
May 22, 2020
Last Verified:
May 1, 2020