A Clinical Trial to Evaluate Safety and Efficacy of a Renal Denervation System in Treatment of Hypertension

• Status: Unknown status
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicentre clinical trial to evaluate safety and efficacy of renal denervation system in treatment of hypertension. Hypertensive patients who meet enrollment criteria will be randomized into treatment group who will receive standardized drugs and renal denervation treatments, or control group who will receive standardized drugs and a sham procedure (renal artery angiography only without denervation). The patients will be monitored for blood pressure changes and any adverse events for 6 months. The safety and efficacy of the device will be evaluated by comparing blood pressure levels and adverse event episodes between the two groups.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Golden Leaf MedTec Co. Ltd
• Treatments: Antihypertensive Agents

Criteria

Inclusion Criteria:

• Ages of 18 to 65, male or female;

• Patients who have been taking 2 or more anti-hypertensive drugs for at least 4 weeks, with mean BP ≥150/90 mmHg based on 3 office blood pressure measurements, or ASBP≥135 mmHg based on 24 hr blood pressure monitoring;

• Heart beats at rest ≥70 bpm

• Confirmed diagnosis of primary hypertension or CKD hypertension;

• Main renal artery, with or without accessary renal arteries;

• Agrees to take part in the trial and signs the written, informed consent.

Exclusion Criteria:

• Pregnant or plan to become pregnant, or Breastfeeding;

• Renal artery abnormalities that are inappropriate for the procedure (renal stenosis ≥50%, aneurysm, renal artery diameter <4mm or length<20mm) ;

• Only one kidney or kidney transplant recipient

• Prior renal artery interventional procedures or prior RDN treatment;

• Any conditions affecting accuracy of blood pressure measurement, such as diameter of upper arm too large for the cuff or severe arrhythmia;

• Secondary hypertension other than CKD hypertension;

• Pseudohypertension;

• History of orthostatic hypotension;

• Average systolic blood pressure (ASBP) <135mmHg based on ambulatory 24 hours blood pressure monitoring;

• History of hospitalization for hypertensive emergencies within one year;

• Type I diabetes;

• Primary pulmonary hypertension;

• Bleeding tendency or other coagulation related diseases;

• Abnormal blood electrolytes levels;

• History of stroke or transit ischemic attack (TIA) within 2 weeks;

• Malignant tumor or end-stage illnesses;

• Severe peripheral vascular diseases, aneurysm;

• Acute coronary events within 2 weeks;

• Patients who need assisted breathing with mechanical ventilation;

• Acute or severe systemic infection;

• Patients with pacemaker implantation;

• Major surgery or trauma in 30 days before enrollment;

• Plan to receive surgery or cardiovascular interventional procedures in 6 months;

• Have been enrolled for other drug or device trial;

• Known drug or alcohol dependency, unable to comprehend the trial protocol, unwilling or unable to comply with follow-ups in accordance with the protocol;

• Other conditions that deem unsuitable for the procedure, in the opinions of investigators.