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

Last updated: October 6, 2019
Sponsor: Terumo Europe N.V.
Overall Status: Terminated

Phase

N/A

Condition

Circulation Disorders

Stress

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02295683
T124E2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  • 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% ofthe measurements.

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

Exclusion

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 accidentwithin 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 5years.

  • Patient unable to do correct FU.

  • Unable to take correct ambulatory BP.

  • Primary hyperaldosteronism.

  • Known lack of adherence to medical treatment.

Study Design

Total Participants: 18
Study Start date:
November 01, 2014
Estimated Completion Date:
September 04, 2017

Study 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

Connect with a study center

  • Clinical Center of Serbia

    Belgrade,
    Serbia

    Site Not Available

  • Hospital Galdakao

    Galdakao,
    Spain

    Site Not Available

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