International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension

NCT01836146 | Completed DMC

• 1 other identifier: 1202
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.

Conditions

Hypertension; Renal Denervation

Outcome Measures

Primary Outcomes (2)

• Safety Objective

  To characterize the rate of serious procedural and device related adverse events from date of procedure through 6 months post procedure, as adjudicated by the Clinical Events Committee (CEC).

  6 months

• Performance objective

  To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline.

  6 months

Secondary Outcomes (3)

• Change in Ambulatory Blood Pressure

  1 month, 3 month, 6 month, 12 month, 18 month, 2 years

• New renal artery stenosis or aneurysm at the site of ablation

  1 month, 3 month, 6 month, 12 month, 18 month, 2 years

• Renal Function Change

  1 month, 3 month, 6 month, 12 month, 18 month, 2 years

Study Arms (1)

Renal Artery Ablation

EXPERIMENTAL

Device: EnligHTN™ Renal Artery Ablation Catheter

Interventions

EnligHTN™ Renal Artery Ablation Catheter DEVICE

Renal Artery Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 and ≤ 80 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 ≥ 160 mmHg at confirmatory visit
• Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg during the two week screening period
• Subject has an office Systolic Blood Pressure that remains ≥160 mmHg despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic or subject was previously on diuretic but documented to be diuretic intolerant, for a minimum of 14 days prior to the procedure and with an expectation to maintain for a minimum of 180 days post procedure.

You may not qualify if:

• Subject has significant renovascular abnormalities such as renal artery stenosis \> 30% in either renal artery
• 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 the Study Investigator
• Subject has a life expectancy less than 12 months, as determined by a Study 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 or \<20 mm in length
• Subject has an estimated Glomerular Filtrate Rate (eGFR) \<45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
• Subject has Diabetes Mellitus Type I
• Subject has multiple main renal arteries in either kidney
• Subject has an identified secondary cause of hypertension (for example, including, but not limited to, Polycystic kidney disease, Cushing's syndrome, Aldosteronism)
• Subject has evidence of significant abdominal aortic aneurysm (defined as maximum diameter of \>4 cm)
• Subject has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days prior to enrollment
• Subject is expected to have cardiovascular intervention within the next 180 days

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

St Andrews Hospital

Adelaide, South Australia, Australia

Location

St. Vincent's Hospital Melbourne

Fizroy, Victoria, Australia

Location

Monash Heart/Southern Health

Melbourne, Victoria, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2015
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

NZ (2); AU (4)