Observational Study of the EnligHTN Renal Denervation System in Europe

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02006758
• Collaborator: (none)
• Enrollment: 68
• Locations: 13
• Duration (Months): 42
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Device: EnligHTN™ Renal Denervation System

Detailed Description

The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

Study Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: EnligHTN European Observational Study
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Uncontrolled hypertension patients The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension.	Device: EnligHTN™ Renal Denervation System; The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).

Outcome Measures

Primary Outcome Measures

1. Mean Change in Office Systolic Blood Pressure at 6 Months [Baseline and 6 months]

Secondary Outcome Measures

1. Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure [30 days]

2. Mean Change in Office Systolic Blood Pressure at 1 Month [Baseline and 1 month]

3. Mean Change in Office Diastolic Blood Pressure at 1 Month [Baseline and 1 month]

4. Mean Change in Ambulatory Systolic Blood Pressure at 1 Month [Baseline and 1 month]

5. Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month [Baseline and 1 month]

6. Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month [1 month]

7. Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months [Baseline and 6 months]

8. Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months [Baseline and 12 months]

9. Renovascular Safety at 6 Months (Renal Artery Stenosis) [6 months]

   Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.

10. Mean Change in Office Systolic Blood Pressure at 12 Months [Baseline and 12 months]

11. Mean Change in Office Diastolic Blood Pressure at 6 Months [Baseline and 6 months]

12. Mean Change in Office Diastolic Blood Pressure at 12 Months [Baseline and 12 months]

13. Mean Change in Ambulatory Systolic Blood Pressure at 6 Months [Baseline and 6 months]

14. Mean Change in Ambulatory Systolic Blood Pressure at 12 Months [Baseline and 12 months]

15. Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months [Baseline and 6 months]

16. Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months [Baseline and 12 months]

17. Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months [6 months]

18. Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is planned to undergo a renal denervation procedure for the treatment of hypertension

• 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 has office SBP ≥ 140 mmHg

• Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic)

Exclusion Criteria:

• Subject has known 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 a history of hemodynamically significant valvular heart disease

• Subject has blood clotting abnormalities

• Subject life expectancy is < 12 months, as determined by the Study Investigator

• Subject is participating in another clinical study which has the potential to impact his/her hypertension 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 known renal arteries with diameter(s) < 4 mm

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Civil Marie Curie	Lodelinsart	Hainaut	Belgium	6042
2	North Estonia Medical Centre	Tallinn	Harjuma	Estonia	13419
3	Dr. Gianluigi Patelli	Alzano Lombardo	Lombardia	Italy	24068
4	Instituto Clinico Citta Studi	Milano	Lombardy	Italy	20131
5	Policlinico San Marco	Osio Sotto	Lombardy	Italy	24040
6	Clinica San Gaudenzio	Novara	Peimonte	Italy	28100
7	Hospital de Santa Cruz	Carnaxide	Lisbon	Portugal	2795-523
8	Hospital Juan Ramon Jimenez	Huelva	Andalucia	Spain	21005
9	Clinica Universitaria de Navarra	Pamplona	Navarra	Spain	31008
10	Hopspital Infanta Cristina	Badajoz		Spain	06010
11	Hospital Universitari i Politecnic La Fe	Valencia		Spain	46206
12	Hospital Xeral-Cies de Vigo	Vigo		Spain	36204
13	Craigavon Area Hospital	Portadown	Nirelnd	United Kingdom	BT63 5QQ

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: José Diaz, MD, Hospital Juan Ramon Jimenez, Huelva, Spain

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 25, 2014

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02006758
• Other Study ID Numbers: CV-12-064-EU-HT
• First Posted: Dec 10, 2013
• Last Update Posted: Oct 16, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Period Title: Overall Study
STARTED	68
Underwent Renal Denervation	67
1-month Follow up	66
6-month Follow up	60
12-month Follow up	55
COMPLETED	55
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with the EnligHTN System for the treatment of uncontrolled hypertension
Overall Participants	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (11.8)
Sex: Female, Male (Count of Participants)
Female	30 44.1%
Male	37 54.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Belgium	11 16.2%
Estonia	3 4.4%
Italy	27 39.7%
Portugal	5 7.4%
Spain	16 23.5%
United Kingdom	6 8.8%
Physical Assessment - Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	88.8 (19.3)
Physical Assessment - Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	169.8 (10.0)
Physical assessment - Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.5 (5.0)
Hypertension (HTN) (years) [Mean (Standard Deviation) ]
Years since HTN diagnosis	12.8 (11.5)
Years since subject was on anti-HTN meds	11.1 (11.8)
Renal artery atherosclerosis (Count of Participants)
Count of Participants [Participants]	2 2.9%
Renal artery atherosclerosis percentage (percentage (%)) [Mean (Standard Deviation) ]
Percentage (%) of atherosclerosis on the right	25 (0.0)
Percentage (%) of atherosclerosis on the left	NA (NA)
Renovascular Hypertension (Count of Participants)
Count of Participants [Participants]	0 0%
Other Renal Disease (Count of Participants)
Count of Participants [Participants]	11 16.2%
Cardiovascular History (Count of Participants)
None	43 63.2%
Myocardial Infarction	4 5.9%
Coronary Artery Disease	14 20.6%
Coronary Artery Bypass Graft	2 2.9%
Percutaneous Coronary Intervention	10 14.7%
Abdominal Aortic Aneurysm	0 0%
Valvular Disease	3 4.4%
Arrhythmias	6 8.8%
Cardiomyopathy	9 13.2%
Neurological history (Count of Participants)
None	60 88.2%
Cerebrovascular accident	2 2.9%
Other	5 7.4%
Additional Medical History (Count of Participants)
Hyperlipidemia	27 39.7%
Diabetes	25 36.8%
Smoker	21 30.9%
Significant Alcohol intake	5 7.4%
Office Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Systolic Blood Pressure	163.7 (22.5)
Diastolic Blood Pressure	90.3 (15.2)
Ambulatory Blood Pressure (mmHg) [Mean (Standard Deviation) ]
24 Hour Systolic Blood Pressure	155.0 (16.9)
24 Hour Diastolic Blood Pressure	86.6 (14.7)
Day time Systolic Blood Pressure	158.1 (17.1)
Day time Diastolic Blood Pressure	89.2 (14.9)
Night time Systolic Blood Pressure	149.6 (23.6)
Night time Diastolic Blood Pressure	80.5 (16.1)
Heart Rate (bpm (beats per minute)) [Mean (Standard Deviation) ]
Office Heart Rate	69.4 (11.7)
24-Hour Ambulatory Heart Rate	67.7 (12.1)
Day time Ambulatory Heart Rate	70.3 (13.5)
Night time Ambulatory Heart Rate	64.2 (13.6)
Participants on stable anti-HTN medication prior to enrollment (Count of Participants)
Count of Participants [Participants]	67 98.5%
Number of anti-HTN medications participant currently takes (medications) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [medications]	4.3 (1.0)
Antiarrhythmic Medication currently being taken (Count of Participants)
ACE/angiotensin 2 receptor/direct renin inhibitors	48 70.6%
Beta blockers	42 61.8%
Calcium Channel Blocker	48 70.6%
Diuretics	61 89.7%
Other hypertensive medication	40 58.8%
Serum creatinine concentration (umol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [umol/L]	86.1 (27.9)
Estimated Glomerular Filtration Rate (eGFR) (mL/min per 1.73 m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/min per 1.73 m^2]	79.1 (24.5)
Urine Albumin to Creatinine Ratio (mg/g) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/g]	89.6 (235)

Outcome Measures

1. Primary Outcome

Title	Mean Change in Office Systolic Blood Pressure at 6 Months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

58 out of 67 participants analyzed for primary outcome measure of office systolic blood pressure at 6 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	58
Mean (Standard Deviation) [mmHg]	-13.6 (29.2)

2. Secondary Outcome

Title	Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	67
Back Pain	1 1.5%
Renal Artery Stenosis	1 1.5%
Urinary Tract Infection	1 1.5%
Viral Syndrome	1 1.5%

3. Secondary Outcome

Title	Mean Change in Office Systolic Blood Pressure at 1 Month
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

61 out of 67 participants were analyzed for mean reduction in office Systolic Blood Pressure at 1 month.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	61
Mean (Standard Deviation) [mmHg]	-13.0 (28.2)

4. Secondary Outcome

Title	Mean Change in Office Diastolic Blood Pressure at 1 Month
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

61 out of 67 analyzed for mean change in office Diastolic Blood Pressure at 1 month

Arm/Group Title	Uncontrolled Hypertension Patients
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	61
Mean (Standard Deviation) [mmHg]	-4.6 (16.7)

5. Secondary Outcome

Title	Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

23 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 1 month

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	23
Mean (Standard Deviation) [mmHg]	-6.8 (18.2)

6. Secondary Outcome

Title	Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

23 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 1 month.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	23
Mean (Standard Deviation) [mmHg]	-3.6 (9.7)

7. Secondary Outcome

Title	Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

62 out of 67 participants analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 1 month.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	62
Count of Participants [Participants]	24 35.3%

8. Secondary Outcome

Title	Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

48 out of 67 analyzed for renal function change based on eGFR at 6 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	48
Mean (Standard Deviation) [mL/min per 1.73 m^2]	-1.0 (21.3)

9. Secondary Outcome

Title	Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

38 out of 67 analyzed for renal function change based on eGFR at 12 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	38
Mean (Standard Deviation) [mL/min per 1.73 m^2]	-2.2 (21.1)

10. Secondary Outcome

Title	Renovascular Safety at 6 Months (Renal Artery Stenosis)
Description	Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	67
Count of Participants [Participants]	1 1.5%

11. Secondary Outcome

Title	Mean Change in Office Systolic Blood Pressure at 12 Months
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

54 out of 67 participants analyzed for mean change in office Systolic Blood Pressure at 12 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	54
Mean (Standard Deviation) [mmHg]	-13.8 (24.7)

12. Secondary Outcome

Title	Mean Change in Office Diastolic Blood Pressure at 6 Months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

58 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 6 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	58
Mean (Standard Deviation) [mmHg]	-6.7 (17.6)

13. Secondary Outcome

Title	Mean Change in Office Diastolic Blood Pressure at 12 Months
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

54 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 12 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	54
Mean (Standard Deviation) [mmHg]	-7.1 (16.1)

14. Secondary Outcome

Title	Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

29 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 6 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	29
Mean (Standard Deviation) [mmHg]	-10.8 (13.7)

15. Secondary Outcome

Title	Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

25 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 12 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	25
Mean (Standard Deviation) [mmHg]	-6.4 (19.5)

16. Secondary Outcome

Title	Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

29 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 6 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	29
Mean (Standard Deviation) [mmHg]	-5.6 (7.1)

17. Secondary Outcome

Title	Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

25 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 12 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	25
Mean (Standard Deviation) [mmHg]	-4.2 (10.4)

18. Secondary Outcome

Title	Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

59 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 6 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	59
Count of Participants [Participants]	21 30.9%

19. Secondary Outcome

Title	Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

55 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 12 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	55
Count of Participants [Participants]	19 27.9%

20. Post-Hoc Outcome

Title	Serum Creatinine Concentration at 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

55 out of 67 analyzed for serum creatinine concentration at 6 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	55
Mean (Standard Deviation) [umol]	227.9 (1013.1)

21. Post-Hoc Outcome

Title	Serum Creatinine Concentration at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

46 out of 67 analyzed for serum creatinine concentration at 6 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	46
Mean (Standard Deviation) [umol]	90.2 (29.5)

22. Post-Hoc Outcome

Title	Urine Albumin to Creatinine Ratio at 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

17 out of 67 analyzed for serum creatinine concentration at 6 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	17
Mean (Standard Deviation) [mg/g]	212.8 (635.1)

23. Post-Hoc Outcome

Title	Urine Albumin to Creatinine Ratio at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

14 out of 67 analyzed for serum creatinine concentration at 6 months.

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	14
Mean (Standard Deviation) [mg/g]	179.0 (373.1)

24. Post-Hoc Outcome

Title	Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

55 out of 67 participants were analyzed for number of anti-hypertensive medications taken at 12 months

Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
Measure Participants	55
Mean (Standard Deviation) [number of medications]	3.7 (1.5)

Adverse Events

Time Frame	Adverse event data were collected over 12 months.
Arm/Group Title	Uncontrolled Hypertension Participants
Arm/Group Description	Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension
All Cause Mortality
	Uncontrolled Hypertension Participants
	Affected / at Risk (%)	# Events
Total	1/68 (1.5%)
Serious Adverse Events
	Uncontrolled Hypertension Participants
	Affected / at Risk (%)	# Events
Total	8/68 (11.8%)
Cardiac disorders
Myocardial Infarction	1/68 (1.5%)	1
Myocardial Ischemia	1/68 (1.5%)	1
Sustained Atrial Fibrillation	1/68 (1.5%)	1
Gastrointestinal disorders
Inguinal hernia	1/68 (1.5%)	1
Infections and infestations
Sepsis	1/68 (1.5%)	1
Viral Syndrome	1/68 (1.5%)	1
Vascular disorders
Renal Artery Stenosis	1/68 (1.5%)	1
VASC Vessel Stenosis	1/68 (1.5%)	1
Other (Not Including Serious) Adverse Events
	Uncontrolled Hypertension Participants
	Affected / at Risk (%)	# Events
Total	5/68 (7.4%)
Cardiac disorders
Arterial Hypertension/Hypertension	1/68 (1.5%)	1
General disorders
Drug Side Effect	1/68 (1.5%)	1
Infections and infestations
Bacterial Infections of the Skin	1/68 (1.5%)	1
Urinary Tract Infections	1/68 (1.5%)	1
Musculoskeletal and connective tissue disorders
Back Pain	1/68 (1.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.