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

Primary Hypertension Clinical Trial

Official title:

A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511313
• Other study ID #: SNP-CT-1601
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2018
• Last updated: April 26, 2018
• Start date: April 11, 2018
• Est. completion date: September 2020

Study information

• Verified date: April 2018
• Source: Synaptic Medical Limited
• Contact: Jiayi Wang
• Phone: +86-18511291205
• Email: jiayi.wang[@]synapticmed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.

• Heart failure (NYHA classification ?-?).

• 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.

Related Conditions & MeSH terms

• Hypertension
• Primary Hypertension

Intervention

Device:
• 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.

Diagnostic Test:
• Renal angiography
A renal angiography according to standard procedure.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Synaptic Medical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in serum creatinine	Safety outcome assessment	from baseline to 3 months post-procedure and 6 months post-procedure
Other	Incidence of renal stenosis	Safety outcome assessment	6 months post-procedure
Other	Other acute and chronic safety evaluating by the incidence of major adverse event	Safety outcome assessment	6 months post-procedure
Primary	Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring	Primary effective outcome measure	from baseline to 3 months post-procedure
Secondary	Change in office systolic blood pressure	Secondary effective outcome measure	from baseline to 3 months post-procedure
Secondary	Classes of anti-hypertensive medicine taken by participants	Secondary effective outcome measure	6 months post-procedure
Secondary	Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)	Secondary effective outcome measure	from 3 months post-procedure to 6 months post-procedure