Status:
TERMINATED
Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry
Lead Sponsor:
Terumo Europe N.V.
Conditions:
Resistant Hypertension
Eligibility:
All Genders
18+ years
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 accor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02295683
Start Date
November 1 2014
End Date
September 4 2017
Last Update
October 8 2019
Active Locations (2)
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1
Clinical Center of Serbia
Belgrade, Serbia
2
Hospital Galdakao
Galdakao, Spain