Observational Study of the EnligHTN Renal Denervation System in Europe

EnligHTN European Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with uncontrolled hypertension

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure		30 days
Mean Change in Office Systolic Blood Pressure at 1 Month		Baseline and 1 month
Mean Change in Office Diastolic Blood Pressure at 1 Month		Baseline and 1 month
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month		Baseline and 1 month
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month		Baseline and 1 month
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month		1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months		Baseline and 6 months
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months		Baseline and 12 months
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
Mean Change in Office Systolic Blood Pressure at 12 Months		Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 6 Months		Baseline and 6 months
Mean Change in Office Diastolic Blood Pressure at 12 Months		Baseline and 12 months
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months		Baseline and 6 months
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months		Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months		Baseline and 6 months
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months		Baseline and 12 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months		6 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months		12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: José Diaz, MD, Hospital Juan Ramon Jimenez, Huelva, Spain

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CV-12-064-EU-HT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No