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NCT02761811Active, not recruiting

Sympathetic Mapping/ Ablation of Renal Nerves Trial

A Prospective, Multicenter, Single Blind, Randomized and Sham Controlled Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension (SMART Trial)

Source: ClinicalTrials.gov · Last updated 2 Aug 2023

Brief summary (registry, in English)

To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
220 (actual)
First submitted
3 May 2016
Start date
30 Jun 2016
Primary completion date
25 Aug 2022
Lead sponsor
SyMap Medical (Suzhou), Ltd.
NCT number
NCT02761811

What you commit to

  • Study type: Interventional
  • Participants enrolled: 220
  • From 30 Jun 2016 to the primary completion date, 25 Aug 2022
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • During running in period, using antihypertensive drugs other than standardized antihypertensive drugs
  • Participated other clinical trials including both drug and medical device studies within 3 months from current study
  • Patients previously or currently suffering from following diseases:
    • (1) essential pulmonary arterial hypertension, (2) type I diabetes, (3) patients with severe cardiac valvular stenosis who have contradictions and cannot rolerant to significantly reduce blood pressure, (4) within half year, patients had myocardial infraction, unstable angina, syncope or cerebrovascular accidents, (5) history of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyreosis, (6) any disease conditions interfering the measurement of blood pressure (for instance, severe peripheral artery diseases, abdominal artery aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severe anemia), (7) plans to have surgery or cardiovascular interventions within 6 months, (8) alcohol abuse or unknown drug dependence history, (9) neuroticisms such as depression or anxiety disorders, (10) non-compliant patients who are unable to follow the study protocol per physician's requests.
    • 11\. Any contradictions to conduct renal artery stimulation and ablation

Other illness

  • Renal artery anatomy is unqualified including: (1) diameter \<4mm or treatable length \<25mm, (2) multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%, (3) renal artery stenosis \>50% or any renal artery aneurysms on either side, (4) history of renal artery PTA, including balloon angioplasty and stenting.

Lab values

  • eGFR \<45mL/min/1.73m2 (MDRD formula)

Other

  • Hospitalized within one year due to hypertensive crisis
  • Average 24-hour systolic blood pressure \<130mmHg and ABPM systolic blood pressure during daytime ≤ 135mmHg, and ABMP systolic blood pressure during nighttime ≤ 120mmHg
  • Pulse pressure \>80mmHg
  • Female with pregnant or lactating, or having plans for pregnancy within 1 year
  • Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy)

Who the study is looking for

  • Male and non-pregnant female subjects, 18≤age≤65
  • Essential hypertension
  • Office systolic blood pressure ≥150mmHg and ≤180mmHg; and resting heart rate ≥70 bpm without taking beta blocker(Resting heart rate does not taken into account if beta blocker is taken)
  • Average 24-hour ABPM systolic blood pressure ≥130mmHg, or ABPM systolic blood pressure during daytime ≥ 135mmHg, or ABPM systolic blood pressure during nighttime ≥ 120mmHg
  • History of hypertension is longer than 6 months
  • Patient with poor blood pressure control after 6 months of antihypertensive drug therapy, understands the purpose of this study, and is willing to participate and sign the Informed Consent; then the patient receives standard antihypertensive drug treatment (at least two drugs) for at least 28 days, drug compliance ≥80%, office systolic blood pressure ≥150 mmHg and ≤180 mmHg.
  • Patient is compliant and willing to complete clinical follow-up.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
The Second Afflicted Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Daqing Oilfield General Hospital
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DaqingChinaUnknown status
Nanjing First Hospital
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NanjingChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Shanghai Zhongshan Hospital, Fudan University
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ShanghaiChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
Hebei General Hospital
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ShijiazhuangChinaUnknown status
Norman Bethune International Peace Hospital
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ShijiazhuangChinaUnknown status
Taiyuan Central Hospital
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TaiyuanChinaUnknown status
Tianjin First Center Hospital
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TianjinChinaUnknown status
Renmin Hospital of Wuhan University
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WuhanChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.