NCT04917393Unknown不适用
Multi-Organ Denervation to RedUce Sympathetic Drive, Multi-Center, Prospective Feasibility Study - The MODUS ON MED Study
Metavention4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年9月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Rate of SADEs
研究概览
简要总结
The objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control.
详细描述
This study is a prospective, single-arm, multi-center, sham contollred trial to evaluate the initial safety and performance of multi-organ denervation for the treatment of hypertension and type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded during the procedure by a combination of the conscious sedation, sensory isolation and sedation and lack of familiarity of the procedural details and duration (i.e., subjects will not know the difference between the renal angiography procedure alone and the renal angiography and denervation procedure).
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years old
- •Office systolic blood pressure (SBP) ≥ 135 mmHg or on a stable dose of antihypertensive medication(s) for at least 30 days
- •Documented daytime systolic ambulatory blood pressure (ABP) ≥ 135 and < 175 mmHg
- •HbA1c ≥7.5% - ≤11.0% on a stable dose of antidiabetic medication(s) for at least 90 days
- •Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female)
排除标准
- •Renal artery (RA) anatomy on either side OR common hepatic artery (CHA) anatomy, ineligible for treatment including the following:
- •CHA OR RA artery diameter < 4.0 mm or > 7.0 mm
- •CHA or RA length that does not allow adequate landing zone for at least one iRF balloon placement and treatment
- •Only one functioning kidney
- •Presence of abnormal kidney tumors
- •CHA or RA with aneurysm
- •Pre-existing stent or history of angioplasty in target arteries
- •Fibromuscular dysplasia of the CHA or renal arteries
- •Presence of CHA OR RA diameter stenosis >30%
- •Individual lacks appropriate arterial anatomy for treatment or for maneuvering of the device from the femoral artery to the target location(s)
- •Prior renal denervation procedure
- •Type 1 diabetes mellitus
- •Use of insulin within 90 days prior to Index Procedure
- •eGFR < 45 mL/min per 1.73 m2
- •One or more documented severe hypertensive crisis (persistent or elevated hypertension > 180 mmHg accompanied by clinical symptoms) in the 90 days prior to Index Procedure
- •One or more documented hyperglycemia episodes (requiring hospitalization) in the 90 days prior to Index Procedure
- •One or more Severe hypoglycemic events (severe cognitive impairment requiring external assistance for recovery) in the 90 days prior to Index Procedure
- •Evidence of active infection within 7 days prior to Index Procedure
- •Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
- •Any history of cerebrovascular event (e.g., stroke, transient ischemic event, and cerebrovascular accident) within 6 months prior to Index Procedure
- •Myocardial infarction within 6 months of Index Procedure
- •Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent.
- •Documented confirmed episode(s) of stable or unstable angina within 6 months prior to Index Procedure
- •Documented history of persistent or permanent atrial tachyarrhythmia
- •Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- •Night shift workers
- •Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed.
- •Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator)
- •Known Primary pulmonary hypertension (HTN) (> 60 mmHg pulmonary artery or right ventricular systolic pressure)
- •Individual has known pheochromocytoma, Cushing syndrome, primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism. (Note: Treated hyperthyroidism and treated hypothyroidism are permissible.)
- •A history of bariatric surgery, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
- •Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the CHA
- •History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
- •ALT or AST greater than 200 U/L
- •History or evidence of active / suspected chronic liver or biliary disease including Hepatitis B, Hepatitis C, autoimmune hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis, Wilson's disease, alpha-1-antitrypsin deficiency, hemochromatosis, drug-induced liver disease, bile duct dilation and obstruction, symptomatic gallstones, liver cancer or liver cirrhosis. Note: subjects with past symptomatic gallstones and a cholecystectomy are not excluded.
- •Current or chronic pancreatitis
- •Documented contraindication or allergy to contrast medium not amenable to treatment
- •Limited life expectancy of < 1 year at the discretion of the investigator
- •Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
- •Pregnant, nursing, or planning to become pregnant (documented negative pregnancy test result required documented within a maximum of 7 days before Index Procedure for all women of childbearing potential)
- •Concurrent enrollment in any other investigational drug or device trial (participation in noninterventional registries is acceptable)
结局指标
主要结局
Rate of SADEs
时间窗: Index Procedure through 30 days.
The primary safety endpoint is the incidence rate of serious adverse device effects (SADEs)
次要结局
- Change in Glycemic control - HbA1c(90 days, 180 days and 365 days)
- Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring(90, 180 and 365 days)
- Change in automated unobserved average office blood pressure(90, 180 and 365 days)
- Change in Glycemic control - fasting glucose(90 days, 180 days and 365 days)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
不适用
Evaluation of the Integrated Radio Frequency Denervation System to Reduce Sympathetic DriveHypertensionType 2 DiabetesACTRN12620000412932Metavention, Inc.45
终止
不适用
Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN RegistryResistant HypertensionNCT02295683Terumo Europe N.V.18
招募中
3 期
Cardiac Sympathetic Denervation for Prevention of Ventricular TachyarrhythmiasVentricular FibrillationSudden Cardiac DeathCardiomyopathyVentricular TachycardiaNCT01013714University of California, Los Angeles40
已完成
3 期
Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial FibrillationHypertensionAtrial FibrillationNCT01873352Meshalkin Research Institute of Pathology of Circulation302
Unknown
不适用
Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial FibrillationHypertensionAtrial FibrillationNCT01814111The First Affiliated Hospital with Nanjing Medical University100