IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

NCT ID: NCT01705080

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 276 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-17
• Study Completion Date: 2019-11-27

Brief Summary

The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

Detailed Description

This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.

Conditions

Hypertension; Blood Pressure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A - EnligHTN for Severe Resistant HTN

• Office systolic Blood Pressure ≥160 mmHg
• Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
• Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula

EnligHTN

Intervention Type: DEVICE

Renal artery ablation with EnligHTN system used for all groups

B - EnligHTN for Resistant HTN

• Office systolic Blood Pressure ≥140 mmHg
• Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
• Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula

EnligHTN

Intervention Type: DEVICE

Renal artery ablation with EnligHTN system used for all groups

C - EnligHTN for Resistant HTN & CKD

• Office systolic Blood Pressure ≥140 mmHg
• Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
• Patient has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula

EnligHTN

Intervention Type: DEVICE

Renal artery ablation with EnligHTN system used for all groups

Interventions

EnligHTN

Renal artery ablation with EnligHTN system used for all groups

Intervention Type: DEVICE

Eligibility Criteria

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 has office Systolic Blood Pressure ≥ 140 mmHg at confirmatory 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 on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.

Exclusion Criteria

• 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 Investigator
• Subject is participating in another clinical study which has the potential to impact their 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 renal arteries with diameter(s) < 4 mm in diameter
• Subject has an estimated GFR <15 mL/min per 1.73 m^2 using the MDRD formula
• Subject had a renal transplant or is awaiting a renal transplant
• Subject has blood clotting abnormalities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melvin Lobo, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

NIHR Barts Cardiovascular Biomedical Research Unit

Stephen Worthley, MB BS PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Prince Charles Hospital

Chermside, , Australia

Royal Melbourne Hospital - City Campus

Parkville, , Australia

Royal Perth Hospital

Perth, , Australia

CHU de Besancon - Jean Minjoz

Besançon, Franche-Comte, France

Institute Cardio. Paris-Sud-Institut Jacques Cartier

Paris, Massy, France

Hopital de la Croix Rousse

Lyon, , France

St-Etienne CHU

Saint-Etienne, , France

Hopital Civil - Universitaires de Strasbourg

Strasbourg, , France

Klinikum Coburg GmbH

Coburg, Bavaria, Germany

Klinikum Ingolstadt GmbH

Ingolstadt, Bavaria, Germany

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, Germany

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Uni-Klinik Leipzig, Intervent. Angiologie

Leipzig, Saxony, Germany

Universitats-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Universitatsklinikum Essen (AoR)

Essen, , Germany

Universitatsklinikum des Saarlandes

Homburg, , Germany

Klinikum der Johannes-Gutenberg-Universitat

Mainz, , Germany

Krankenhaus der Barmherzigen Bruder

Trier, , Germany

University of Athens, Ippocration Hospital

Athens, , Greece

Fondazione Toscana Gabriele Monasterio CNR

Massa, Tuscany, Italy

Policlinico S.Orsola Malpighi

Bologna, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Haga Ziekenhuis Locatie Leyenburg

The Hague, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Dunedin Public Hospital

Dunedin, , New Zealand

Haukeland Universitetssykehus

Bergen, , Norway

St. Olavs University Hospital

Trondheim, , Norway

Hospital Universitario Donostia

San Sebastián, Basque, Spain

Sahlgrenska University Hospital Gothenburg

Gothenburg, , Sweden

NIHR Barts Cardiovascular Biomedical Research Unit

London, , United Kingdom

Northern General Hospital

Sheffield, , United Kingdom

Countries

Australia; France; Germany; Greece; Italy; Netherlands; New Zealand; Norway; Spain; Sweden; United Kingdom

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1201

Identifier Type: -

Identifier Source: org_study_id