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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511313
Recruitment Status : Unknown
Verified April 2018 by Synaptic Medical Limited.
Recruitment status was:  Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Synaptic Medical Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Hypertension Device: Renal denervation Diagnostic Test: Renal angiography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal denervation
Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications
 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.
Other Name: Renal angiography

Diagnostic Test: Renal angiography
A renal angiography according to standard procedure.
Sham Comparator: Renal angiography
Renal angiography and maintaining anti-hypertensive medications
 Diagnostic Test: Renal angiography
A renal angiography according to standard procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring [ Time Frame: from baseline to 3 months post-procedure ]
    Primary effective outcome measure


Secondary Outcome Measures :
  1. Change in office systolic blood pressure [ Time Frame: from baseline to 3 months post-procedure ]
    Secondary effective outcome measure

  2. Classes of anti-hypertensive medicine taken by participants [ Time Frame: 6 months post-procedure ]
    Secondary effective outcome measure

  3. Incidence of achieving target office systolic blood pressure (office SBP<140mmHg) [ Time Frame: from 3 months post-procedure to 6 months post-procedure ]
    Secondary effective outcome measure


Other Outcome Measures:
  1. Change in serum creatinine [ Time Frame: from baseline to 3 months post-procedure and 6 months post-procedure ]
    Safety outcome assessment

  2. Incidence of renal stenosis [ Time Frame: 6 months post-procedure ]
    Safety outcome assessment

  3. Other acute and chronic safety evaluating by the incidence of major adverse event [ Time Frame: 6 months post-procedure ]
    Safety outcome assessment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511313


Contacts
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Contact: Jiayi Wang +86-18511291205 jiayi.wang@synapticmed.com.cn
Contact: Qing Liu +86-18701241121 qing.liu@synapticmed.com.cn

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Hanhua Wang    +86-010-66119205    jgbgs090101@126.com   
Sub-Investigator: WEI Ma, MD         
Sponsors and Collaborators
Synaptic Medical Limited
Investigators
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Principal Investigator: Yong Huo Peking University First Hospital
More Information
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Responsible Party: Synaptic Medical Limited
ClinicalTrials.gov Identifier: NCT03511313    
Other Study ID Numbers: SNP-CT-1601
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Synaptic Medical Limited:
Primary Hypertension
Renal Denervation
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases