Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry

Terminated

• Conditions: Resistant Hypertension

• Registration Number: NCT02295683
• Lead Sponsor: Terumo Europe N.V.

Brief Summary

The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.

Detailed Description

This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.

This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.

A minimum of 30 patients will be enrolled in Europe

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Primary Completion: 2016-11-30
• Study Completion: 2017-09-04
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-06
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age ≥18 years or minimum age as required by local regulations.

• Patient has been thoroughly informed about this registry and signed Informed Consent Form.

• Patient with true resistant hypertension defined as:

  • Office systolic BP higher than 160 or 150mmHg in case of type 2 diabetes
  • Ambulatory BP with average BP>130mmHg or mean daytime>135mmHg in more than 70% of the measurements.

• Patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension.

Exclusion Criteria

• Previous renal artery intervention (balloon angioplasty or stenting).
• Evidence of renal artery atherosclerosis (defined as a renal artery stenosis >50%).
• Main renal arteries of less than 4mm diameter or less than 20mm in length.
• Presence of multiple main renal arteries in either kidney.
• Estimated glomerular filtration rate <45ml/min per 1,73m2
• Recent myocardial infarction, unstable angina pectoris or cerebrovascular accident within the past 3-6 months.
• False resistant hypertension (pseudo resistance) by using 24h ambulatory BP monitoring (ABPM).
• Secondary arterial hypertension.
• Pregnancy.
• There is another pathological process with well-known life expectancy of less than 5 years.
• Patient unable to do correct FU.
• Unable to take correct ambulatory BP.
• Primary hyperaldosteronism.
• Known lack of adherence to medical treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Pressure (BP) Measurements	Up to 5 year FU	Office BP; Ambulatory BP; Home BP

Trial Locations

Locations (2)

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Hospital Galdakao; 🇪🇸 Galdakao, Spain