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L'essai clinique NCT05590871 pour Hypertension est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
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.
3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
- 714156A
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalRenal Denervation Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance | Flashpoint Renal Denervation System Radio-frequency ablation of renal arterial sympathetic nerves |
Comparateur facticesham For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure.
Subjects maintenance of anti-hypertensive medications. | Placebo 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. |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
24-hour ambulatory mean systolic blood pressure reduction | The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization | Baseline to 6 months |
The incidence of Major Adverse Events (MAE) | Safty outcome | Baseline to 1 month |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Reduction in office systolic and diastolic BP | Secondary outcome | Baseline to 1, 3, 6 months post procedure |
Reduction in average 24h ambulatory diastolic BP | Baseline to 1, 3, 6 months post procedure | |
Reduction in home systolic and diastolic BP | Baseline to 1, 2, 3, 4, 5, 6 months post procedure | |
Percentage of subjects change the number, class, dose of antihypertensive drugs | Baseline to 1, 2, 3, 4, 5, 6 months post procedure | |
Difference in antihypertensive drug burden index | Baseline to 6 months post procedure | |
Subjects level of TTR ( time in target BP range) | Baseline to 6 months post procedure | |
Success rate of the renal interventional therapy procedure | Procedure success rate defined as successful introduction of the catheter, navigation to the treatment site, and there are no procedure-related SAE. | during the procedure |
Incident of acute procedure safety events | 7 days post procedure | |
Incident of chronic procedure safety events | 6 months post procedure | |
Incidence of TTR with MAE, all cause death, stroke and myocardial infarction | Baseline to 6 months post procedure | |
Incidence of adverse events | Baseline to 6 months post procedure | |
Incident of serious adverse events | Baseline to 6 months post procedure | |
Ablation system defect rate | During procedure |
- 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.
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.
Chongqing Municipality
Fujian
Gansu
Guangdong
Guizhou
Heilongjiang
Henan
Jiangsu
Liaoning
Shandong
Shanghai Municipality
Shanxi
Sichuan
Tianjin Municipality
Xinjiang
Yunnan
Zhejiang