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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.
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FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT05590871 est un essai interventionnel pour Hypertension. Son statut actuel est : en recrutement. L'étude a débuté le 31 mars 2023 et vise à recruter 180 participants. Dirigé par Shanghai Hongdian Medical CO., LTD, l'essai devrait être terminé d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 20 novembre 2024.
Résumé succinct
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.
Description détaillée
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.

Titre officiel

3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial

Conditions
Hypertension
Autres identifiants de l'essai
  • 714156A
Numéro NCT
Date de début (réel)
2023-03-31
Dernière mise à jour publiée
2024-11-20
Date de fin (estimée)
2026-12-31
Inscription (estimée)
180
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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:

    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.

Shanghai Hongdian Medical CO., LTD logoShanghai Hongdian Medical CO., LTD
Contact central de l'essai
Contact: Yuehui Yin, MD, +86 13508335502, [email protected]
Contact: Yingxian Sun, MD, +86 13804068889, [email protected]
27 Centres de l'essai dans 1 pays

Chongqing Municipality

The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400037, China
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Chongqing General Hospital, Chongqing, Chongqing Municipality, 401147, China
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Fujian

Cardiovascular Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361016, China
En recrutement

Gansu

The Second Hospital of Lanzhou University, Lanzhou, Gansu, China
En recrutement

Guangdong

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
Pas encore en recrutement

Guizhou

Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
En recrutement

Heilongjiang

First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
En recrutement

Henan

The 7th People's Hospital of Zhengzhou, Zhengzhou, Henan, 450016, China
En recrutement
Zhengzhou Central Hospital, Zhenzhou, Henan, China
En recrutement

Jiangsu

Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China
En recrutement

Liaoning

Ansteel Group General Hospital, Anshan, Liaoning, China
Pas encore en recrutement
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116014, China
Pas encore en recrutement
The First Hospital of China Medical University, Shengyang, Liaoning, 110001, China
En recrutement
The People's Hospital of Liaoning Province, Shenyang, Liaoning, 110017, China
En recrutement

Shandong

Weifang People's Hospital, Weifang, Shandong, China
En recrutement

Shanghai Municipality

Shanghai General Hospital, Shanghai, Shanghai Municipality, 201620, China
En recrutement

Shanxi

The Second Affiliated Hospital of Air Force Medical University of PLA, Xi’an, Shanxi, 710038, China
En recrutement

Sichuan

West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China
En recrutement
First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China
En recrutement
The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646099, China
En recrutement
Mianyang Central Hospital, Mianyang, Sichuan, 621000, China
En recrutement

Tianjin Municipality

Tianjin Chest Hospital, Tianjin, Tianjin Municipality, 300300, China
En recrutement
Tianjin First Central Hospital, Tianjin, Tianjin Municipality, 300384, China
En recrutement

Xinjiang

First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
Pas encore en recrutement

Yunnan

Yan'an Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
En recrutement

Zhejiang

The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, 315016, China
En recrutement
Shenzhen Guangming District People's Hospital, Shenzhen, China
En recrutement