Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2020-09-30

Brief Summary

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The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.

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Detailed Description

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Conditions

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Primary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Renal denervation

Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications

Group Type EXPERIMENTAL

Renal denervation

Intervention Type DEVICE

After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.

Renal angiography

Intervention Type DIAGNOSTIC_TEST

A renal angiography according to standard procedure.

Renal angiography

Renal angiography and maintaining anti-hypertensive medications

Group Type SHAM_COMPARATOR

Renal angiography

Intervention Type DIAGNOSTIC_TEST

A renal angiography according to standard procedure.

Interventions

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Renal denervation

After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.

Intervention Type DEVICE

Renal angiography

A renal angiography according to standard procedure.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Renal angiography

Eligibility Criteria

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Inclusion Criteria

* Individual is ≥18 years and ≤65 years old.
* Primary hypertension.
* Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and\<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and \<170mmHg at the fourth week after screening.

Exclusion Criteria

* Secondary hypertension.
* History of prior renal artery intervention including balloon angioplasty or stenting.
* Renal artery stenosis (≥50%) in either renal artery.
* Main renal arteries with \<4mm, or \>8mm in diameter.
* Main renal arteries with \<20mm in length.
* Estimated glomerular filtration rate (eGFR) of \<40 ml/(min•1.73m2).
* History of Stroke or TIA within 6 months prior to screening period.
* History of Acute coronary syndrome within 6 months prior to screening period.
* Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.
* Heart failure (NYHA classification Ⅲ-Ⅳ).
* Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases.
* History of cancer.
* Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring.
* Acute or severe systemic inflammatory response syndrome.
* Any other serious medical condition unqualified to participate in this study evaluated by investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No