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Active, not recruiting Not applicable

Sympathetic Mapping/ Ablation of Renal Nerves Trial

NCT02761811 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2016-06-30
Last updated
2023-08-02

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator: Radiofrequency ablation of renal arterial sympathetic nerves

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male and non-pregnant female subjects, 18≤age≤65 2. Essential hypertension 3. 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) 4. Average 24-hour ABPM systolic blood pressure ≥130mmHg, or ABPM systolic blood pressure during daytime ≥ 135mmHg, or ABPM systolic blood pressure during nighttime ≥ 120mmHg 5. History of hypertension is longer than 6 months 6. 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. 7. Patient is compliant and willing to complete clinical follow-up. Exclusion Criteria: 1. 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. 2. eGFR \<45mL/min/1.73m2 (MDRD formula) 3. Hospitalized within one year due to hypertensive crisis 4. Average 24-hour systolic blood pressure \<130mmHg and ABPM systolic blood pressure during daytime ≤ 135mmHg, and ABMP systolic blood pressure during nighttime ≤ 120mmHg 5. Pulse pressure \>80mmHg 6. During running in period, using antihypertensive drugs other than standardized antihypertensive drugs 7. Participated other clinical trials including both drug and medical device studies within 3 months from current study 8. Female with pregnant or lactating, or having plans for pregnancy within 1 year 9. Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy) 10. 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

Primary outcome measure(s)

  • The control rate of office systolic blood pressure ( SBP<140mmHg) — 6 months after the treatment
    The control rate of office systolic blood pressure ( SBP\<140mmHg) at 6 months after the treatment
  • Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (<140mmHg) — 6 months after the treatments
    Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (\<140mmHg) at 6 months after the treatment

Trial sites (15)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality
Peking University People's Hospital Beijing Beijing Municipality
The Second Afflicted Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Shenzhen People's Hospital Shenzhen Guangdong
Norman Bethune International Peace Hospital Shijiazhuang Hebei
Hebei General Hospital Shijiazhuang Hebei
Daqing Oilfield General Hospital Daqing Heilongjiang
Renmin Hospital of Wuhan University Wuhan Hubei
Nanjing First Hospital Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
Shanghai Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality
Taiyuan Central Hospital Taiyuan Shanxi
West China Hospital, Sichuan University Chengdu Sichuan
Tianjin First Center Hospital Tianjin Tianjin Municipality

More SyMap Medical (Suzhou), Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02761811 on ClinicalTrials.gov ↗ ← All trials in China