DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications
Trial Parameters
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of renal denervation using DENEX System in patients with hypertension without antihypertensive medication, compared with the sham group.
Eligibility Criteria
Inclusion Criteria: 1. Subject aged 18 to 80 years old at the time of signing the informed consent 2. Subject who is drug-naïve or willing to discontinue current antihypertensive treatment (not on antihypertensive medications for at least 4 weeks prior to Screening Visit 1) at Screening Visit 1 through the 3-month post-procedure visit. Drug-naïve is defined as those with no previous exposure to antihypertensive medications. 3. Subject who meets all of the following blood pressure measurements: * Office Systolic Blood Pressrue (SBP) \< 180 mmHg at Screening Visit 1 * Office SBP ≥ 150 mmHg and \< 180 mmHg, and office diastolic blood pressure (DBP) ≥ 90 mmHg at Screening Visit 2 * 24-h ambulatory SBP ≥ 140 mmHg and \< 170 mmHg at Screening Visit 2 4. Subject who voluntarily decides to participate in this clinical study and sign the written consent. 5. Subject who willing and able to complete all clinical investigation-related procedures and assessments Exclusion Criteria: 1. Subject with