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

Synaptic Medical

Status: Unknown

Conditions: Primary Hypertension

Treatments: Diagnostic Test: Renal angiography; Device: Renal denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03511313

SNP-CT-1601

Details and patient eligibility

About

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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

264 participants in 2 patient groups

Renal denervation

Experimental group

Description:

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

Treatment:

Diagnostic Test: Renal angiography

Device: Renal denervation

Renal angiography

Sham Comparator group

Description:

Renal angiography and maintaining anti-hypertensive medications

Treatment:

Diagnostic Test: Renal angiography