Observational Study of the EnligHTN Renal Denervation System in Europe

Uncontrolled Hypertension Clinical Trial

Official title:

EnligHTN European Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006758
• Other study ID #: CV-12-064-EU-HT
• Status: Completed
• Start date: November 2013
• Est. completion date: May 2017

Study information

• Verified date: August 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

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).

Locations

Country	Name	City	State
Belgium	Hôpital Civil Marie Curie	Lodelinsart	Hainaut
Estonia	North Estonia Medical Centre	Tallinn	Harjuma
Italy	Dr. Gianluigi Patelli	Alzano Lombardo	Lombardia
Italy	Instituto Clinico Citta Studi	Milano	Lombardy
Italy	Clinica San Gaudenzio	Novara	Peimonte
Italy	Policlinico San Marco	Osio Sotto	Lombardy
Portugal	Hospital de Santa Cruz	Carnaxide	Lisbon
Spain	Hopspital Infanta Cristina	Badajoz
Spain	Hospital Juan Ramon Jimenez	Huelva	Andalucia
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Xeral-Cies de Vigo	Vigo
United Kingdom	Craigavon Area Hospital	Portadown	Nirelnd

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Belgium,  Estonia,  Italy,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Office Systolic Blood Pressure at 6 Months		Baseline and 6 months
Secondary	Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure		30 days
Secondary	Mean Change in Office Systolic Blood Pressure at 1 Month		Baseline and 1 month
Secondary	Mean Change in Office Diastolic Blood Pressure at 1 Month		Baseline and 1 month
Secondary	Mean Change in Ambulatory Systolic Blood Pressure at 1 Month		Baseline and 1 month
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month		Baseline and 1 month
Secondary	Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month		1 month
Secondary	Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months		Baseline and 6 months
Secondary	Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months		Baseline and 12 months
Secondary	Renovascular Safety at 6 Months (Renal Artery Stenosis)	Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.	6 months
Secondary	Mean Change in Office Systolic Blood Pressure at 12 Months		Baseline and 12 months
Secondary	Mean Change in Office Diastolic Blood Pressure at 6 Months		Baseline and 6 months
Secondary	Mean Change in Office Diastolic Blood Pressure at 12 Months		Baseline and 12 months
Secondary	Mean Change in Ambulatory Systolic Blood Pressure at 6 Months		Baseline and 6 months
Secondary	Mean Change in Ambulatory Systolic Blood Pressure at 12 Months		Baseline and 12 months
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months		Baseline and 6 months
Secondary	Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months		Baseline and 12 months
Secondary	Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months		6 months
Secondary	Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months		12 months