Active, not recruiting
Not applicable
Sympathetic Mapping/ Ablation of Renal Nerves Trial
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
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)
| Facility | City | Region | Status |
| 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 |
|
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