Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (EnligHTN-I)

Abbott

Status

Completed

Conditions

Hypertension

Treatments

Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01438229

Arsenal (Other Identifier)

CI-10-045-ID-HT

Details and patient eligibility

About

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Full description

Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

All adverse events

Efficacy Marker

Office blood pressure

Enrollment

47 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
Age ≥18 and ≤80 years old
Able and willing to provide written informed consent to participate in the study
Able and willing to comply with the required follow-up schedule

Exclusion criteria

Prior renal artery intervention (balloon angioplasty or stenting)
Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
Multiple main renal arteries in either kidney
Main renal arteries <4 mm in diameter or <20 mm in length
eGFR of <45 mL/min per 1.73 m2 using the MDRD formula
Type 1 diabetes
Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
Others