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

NCT03511313 | Unknown

• 1 other identifier: SNP-CT-1601
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hypertension

Keywords

Primary Hypertension; Renal Denervation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in office systolic blood pressure

  from baseline to 3 months post-procedure

• Classes of anti-hypertensive medicine taken by participants

  6 months post-procedure

• Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)

  from 3 months post-procedure to 6 months post-procedure

Other Outcomes (3)

• Change in serum creatinine

  from baseline to 3 months post-procedure and 6 months post-procedure

• Incidence of renal stenosis

  6 months post-procedure

• Other acute and chronic safety evaluating by the incidence of major adverse event

  6 months post-procedure

Study Arms (2)

Renal denervation

EXPERIMENTAL

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

Device: Renal denervation; Diagnostic Test: Renal angiography

Renal angiography

SHAM COMPARATOR

Renal angiography and maintaining anti-hypertensive medications

Diagnostic Test: Renal angiography

Interventions

Renal denervation 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.

Also known as: Renal angiography

Renal denervation

Renal angiography DIAGNOSTIC_TEST

A renal angiography according to standard procedure.

Renal angiography; Renal denervation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synaptic Medical Corporation: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yong Huo

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayi Wang

CONTACT

+86-18511291205; jiayi.wang@synapticmed.com.cn

Qing Liu

CONTACT

+86-18701241121; qing.liu@synapticmed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 27, 2018
• Study Start: April 11, 2018
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

CN (1)