A Renal Artery Denervation Feasibility Study of the MetAvention Integrated Radio Frequency Denervation System for the Treatment of Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Metavention
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Rate of Major Adverse Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of the study is to evaluate the safety of renal denervation using the iRF System and to understand any potential improvement in hypertension.
Detailed Description
This study is a prospective, single-arm, multi-center, non-randomized trial to evaluate the initial safety and performance of renal denervation with the iRF system for the treatment of hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 and ≤ 80 years old
- •Office SBP ≥ 140 and \< 180 mmHg on a stable dose of antihypertensive medication(s) for at least 30 days
- •Documented daytime systolic ABP ≥ 135 and \< 170 mmHg
- •Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female)
Exclusion Criteria
- •Renal artery anatomy on either side, ineligible for treatment including the following:
- •Main renal artery diameter \< 4.0 mm or \> 7.0 mm
- •Main renal artery length \< 20.0 mm
- •Only one functioning kidney
- •Presence of abnormal kidney tumors
- •Renal artery with aneurysm
- •Pre-existing renal stent or history of renal artery angioplasty
- •Fibromuscular disease of the renal arteries
- •Presence of renal artery stenosis of any origin ≥ 30 %
- •Individual lacks appropriate renal artery anatomy
Outcomes
Primary Outcomes
Rate of Major Adverse Events
Time Frame: Index Procedure through 30 days
Incidence of the following Major Adverse Events (MAEs) * Death (all-cause) * New onset end stage renal disease * Significant embolic events resulting in end-organ damage * Renal artery perforation or dissection requiring intervention * Hospital admission for hypertensive crisis not related to confirmed non-adherence with medications or protocol * New renal stenosis \> 70 %
Secondary Outcomes
- Effects on renal function assessed with glomerular filtration rate(Time Frame: 30, 90, 180 and 365 days)
- Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring(Time Frame: 90, 180 and 365 days)
- Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure(Time Frame: 30, 90, 180 and 365 days)