RecruitingNot ApplicableNCT05590871
FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
Sponsor
Shanghai Hongdian Medical CO., LTD
Enrollment
180 participants
Start Date
Mar 31, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria5
- 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 Criteria18
- Renal artery anatomy failures include:
- Renal artery diameter \<4mm or treatment length \<20mm;
- Renal artery stenosis \>50% or renal aneurysm on either side;
- 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:
- Primary pulmonary hypertension (moderate to severe);
- Type I diabetes;
- History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
- History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
- 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);
- Arranged or planned surgery or cardiovascular intervention within the next 6 months;
- 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.
Interventions
DEVICEFlashPoint renal denervation system
Radio-frequency ablation of renal arterial sympathetic nerves
OTHERSham
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT05590871
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