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

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

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.

Study Overview

• Status: Terminated
• Conditions: Resistant Hypertension
• Intervention / Treatment: Device: Renal Denervation

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia
    • Clinical Center of Serbia
• Spain
  • Galdakao, Spain
    • Hospital Galdakao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with uncontrolled hypertension entitled to receive renal sympathetic denervation treatment per routine hospital practice and according to relevant international, or country specific guidelines

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure (BP) Measurements	Office BP; Ambulatory BP; Home BP	Up to 5 year FU

Collaborators and Investigators

• Sponsor: Terumo Europe N.V.
• Investigators: Principal Investigator: José Ramon Rumoroso, Dr., Hospital Galdakao; Principal Investigator: Palop López, Dr., Hospital San Juan Alicante; Principal Investigator: Mauri, Dr., Germans Trias i Pujol Hospital; Principal Investigator: Perez, Dr., Hospital de Leon; Principal Investigator: Garcia, Dr., Hospital Monteprincipe; Principal Investigator: Goicolea, Dr., Hospital Puerta de Hierro; Principal Investigator: Goran Stankovic, Dr., Clinical Center of Serbia

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): September 4, 2017

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: T124E2