Clinical trial NCT05590871: FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
Official title: 3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Shanghai Hongdian Medical CO., LTD
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.

Detailed description: This trial is a prospective, multi-center, randomized controlled clinical study to verify the safety and efficacy of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the application of renal denervation of essential hypertension，designed to include drug-control research and sham-control resarch. Provide the basis for product registration and marketing and clinical application. Drug-control research include 65 subiects (5 are subjects trained and taught by the experimental group leader unit center, 40 subjects are randomly to the renal artery ablation with durg treatment group, 20 subjects to the drug treatment group). Sham-control research include 180 subjects, will be randomly assigned according to 2:1 (120 subjects in the renal artery ablation with drug treatment group and 60 subjects in the sham procedure with drug treatment group).

Patients will be followed for blood pressure measurement and antihypertensive medication at 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, and 12 months after the procedure. Patients' urine samples will be collected for drug testing (LC-MS/MS) to determine their medication compliance in an independent laboratory.

Eligibility criteria: Inclusion Criteria:

* Males or females aged ≥18 and ≤70 (not pregnant, breastfeeding, and have no reproductive plan within one year);
* Patients with essential hypertension, antihypertensive drug intolerance, and willing to undergo surgical treatment;
* Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg, and pulse pressure difference \<80 mmHg;
* A history of using antihypertensive medication within six months and blood pressure is still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic blood pressure (OSBP) ) ≥ 150 mmHg and \<180 mmHg, diastolic blood pressure (DBP) ≥ 90 mmHg;
* The patients agree to participate in this clinical trial and sign the informed consent form, agreeing to follow-up evaluation under the requirements of the verification protocol.

Exclusion Criteria:

* Renal artery anatomy failures include:

  1. Renal artery diameter \<4mm or treatment length \<20mm;
  2. Renal artery stenosis \>50% or renal aneurysm on either side;
  3. A history of renal artery intervention, including balloon angioplasty or stenting or RDN;
* Glomerular filtration rate (eGFR) \<45mL/min/1.73m2 (MDRD formula);
* History of hospitalization for hypertensive crisis in the past year;
* During the screening and lead-in period, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol;
* Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
* Those who have or are currently suffering from the following diseases or conditions:

  1. Primary pulmonary hypertension (moderate to severe);
  2. Type I diabetes;
  3. History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
  4. History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
  5. Factors that interfere with blood pressure measurement in any case (eg, patients with severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);
  6. Arranged or planned surgery or cardiovascular intervention within the next 6 months;
  7. Patients with malignant tumors and end-stage diseases who survival period is less than 1year;
* Patients with secondary hypertension.
* Patients who are deemed inappropriate to participate in this trial by other investigators.

Primary outcomes:
measure: 24-hour ambulatory mean systolic blood pressure reduction
timeFrame: Baseline to 6 months
measure: The incidence of Major Adverse Events (MAE)
timeFrame: Baseline to 1 month
Secondary outcomes:
measure: Reduction in office systolic and diastolic BP
timeFrame: Baseline to 1, 3, 6 months post procedure
measure: Reduction in average 24h ambulatory diastolic BP
timeFrame: Baseline to 1, 3, 6 months post procedure
measure: Reduction in home systolic and diastolic BP
timeFrame: Baseline to 1, 2, 3, 4, 5, 6 months post procedure
measure: Percentage of subjects change the number, class, dose of antihypertensive drugs
timeFrame: Baseline to 1, 2, 3, 4, 5, 6 months post procedure
measure: Difference in antihypertensive drug burden index
timeFrame: Baseline to 6 months post procedure
measure: Subjects level of TTR ( time in target BP range)
timeFrame: Baseline to 6 months post procedure
measure: Success rate of the renal interventional therapy procedure
timeFrame: during the procedure
measure: Incident of acute procedure safety events
timeFrame: 7 days post procedure
measure: Incident of chronic procedure safety events
timeFrame: 6 months post procedure
measure: Incidence of TTR with MAE, all cause death, stroke and myocardial infarction
timeFrame: Baseline to 6 months post procedure
measure: Incidence of adverse events
timeFrame: Baseline to 6 months post procedure
measure: Incident of serious adverse events
timeFrame: Baseline to 6 months post procedure
measure: Ablation system defect rate
timeFrame: During procedure
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Xiamen
country: China
facility: Cardiovascular Hospital Affiliated to Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Ha'erbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The 7th People's Hospital of Zhengzhou
state: Henan
city: Zhenzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Anshan
country: China
facility: Ansteel Group General Hospital
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shengyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Medical University of PLA
state: Shanxi
city: Chendu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chendu
country: China
facility: First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yan'an Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Shenzhen
country: China
facility: Shenzhen Guangming District People's Hospital
Study officials:
References: