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

Resistant Hypertension Clinical Trial

— Iberis  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02295683
• Other study ID #: T124E2
• Status: Terminated
• Start date: November 2014
• Est. completion date: September 4, 2017

Study information

• Verified date: October 2019
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 4, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Device:
• Renal Denervation

Locations

Country	Name	City	State
Serbia	Clinical Center of Serbia	Belgrade
Spain	Hospital Galdakao	Galdakao

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure (BP) Measurements	Office BP; Ambulatory BP; Home BP	Up to 5 year FU