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

Primary Purpose

Primary Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Renal denervation

Renal angiography

About this trial

This is an interventional treatment trial for Primary Hypertension focused on measuring Primary Hypertension, Renal Denervation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal denervation

Renal angiography

Arm Description

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

Renal angiography and maintaining anti-hypertensive medications

Outcomes

Primary Outcome Measures

Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring

Primary effective outcome measure

Secondary Outcome Measures

Change in office systolic blood pressure

Secondary effective outcome measure

Classes of anti-hypertensive medicine taken by participants

Secondary effective outcome measure

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

Secondary effective outcome measure

Full Information

NCT ID

NCT03511313

First Posted

March 26, 2018

Last Updated

April 26, 2018

Sponsor

Synaptic Medical Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03511313

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 11, 2018 (Actual)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Synaptic Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hypertension

Keywords

Primary Hypertension, Renal Denervation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Renal denervation

Arm Type

Experimental

Arm Description

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

Arm Title

Renal angiography

Arm Type

Sham Comparator

Arm Description

Renal angiography and maintaining anti-hypertensive medications

Intervention Type

Device

Intervention Name(s)

Renal denervation

Other Intervention Name(s)

Renal angiography

Intervention Description

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

Diagnostic Test

Intervention Name(s)

Renal angiography

Intervention Description

A renal angiography according to standard procedure.

Primary Outcome Measure Information:

Title

Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring

Description

Primary effective outcome measure

Time Frame

from baseline to 3 months post-procedure

Secondary Outcome Measure Information:

Title

Change in office systolic blood pressure

Description

Secondary effective outcome measure

Time Frame

from baseline to 3 months post-procedure

Title

Classes of anti-hypertensive medicine taken by participants

Description

Secondary effective outcome measure

Time Frame

6 months post-procedure

Title

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

Description

Secondary effective outcome measure

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Change in serum creatinine

Description

Safety outcome assessment

Time Frame

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

Title

Incidence of renal stenosis

Description

Safety outcome assessment

Time Frame

6 months post-procedure

Title

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

Description

Safety outcome assessment

Time Frame

6 months post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiayi Wang

Phone

+86-18511291205

jiayi.wang@synapticmed.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Qing Liu

Phone

+86-18701241121

qing.liu@synapticmed.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Huo

Organizational Affiliation

Peking University First Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanhua Wang

Phone

+86-010-66119205

jgbgs090101@126.com

First Name & Middle Initial & Last Name & Degree

WEI Ma, MD

12. IPD Sharing Statement

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

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