Observational Study of the EnligHTN Renal Denervation System in Europe

NCT02006758 | Completed Results

• 1 other identifier: CV-12-064-EU-HT
• Study Type: observational
• Target: 68
• Locations: 5 countries
• Sites: 8

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.

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change in Office Systolic Blood Pressure at 6 Months

  Baseline and 6 months

Secondary Outcomes (18)

• 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

Study Arms (1)

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

Interventions

EnligHTN™ Renal Denervation System DEVICE

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).

Uncontrolled hypertension patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with uncontrolled hypertension

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (13)

Hôpital Civil Marie Curie

Lodelinsart, Hainaut, 6042, Belgium

Location

North Estonia Medical Centre

Tallinn, Harjuma, 13419, Estonia

Location

Dr. Gianluigi Patelli

Alzano Lombardo, Lombardy, 24068, Italy

Location

Instituto Clinico Citta Studi

Milan, Lombardy, 20131, Italy

Location

Policlinico San Marco

Osio Sotto, Lombardy, 24040, Italy

Location

Clinica San Gaudenzio

Novara, Peimonte, 28100, Italy

Location

Hospital de Santa Cruz

Carnaxide, Lisbon District, 2795-523, Portugal

Location

Hospital Juan Ramon Jimenez

Huelva, Andalusia, 21005, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hopspital Infanta Cristina

Badajoz, 06010, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46206, Spain

Location

Hospital Xeral-Cies de Vigo

Vigo, 36204, Spain

Location

Craigavon Area Hospital

Portadown, Nirelnd, BT63 5QQ, United Kingdom

Location

Results Point of Contact

• Title: Rebecca Maslow, MA, Clinical Project Manager
• Organization: Abbott

rebecca.maslow@abbott.com

+1 651-756-5564

Study Officials

• José Diaz, MD

  Hospital Juan Ramon Jimenez, Huelva, Spain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 16, 2019
• Results First Posted: October 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); ES (1); GB (1); IT (4); BE (1)