A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension
Trial Parameters
Brief Summary
HQ-HTN-K01-02 is a prospective, multicenter, single arm, open label, first-in-human study to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications
Eligibility Criteria
Inclusion Criteria: Subjects are deemed eligible for this clinical trial only if they meet all of the following criteria: 1. Male and female patients aged between 19 and 79 years old 2. Resistant hypertensive patients on stable regimen of at least 3 antihypertensive medications\* for at least 4weeks prior Screening1 and those who are willing to continue existing antihypertensive medications during run- in period and till 3 months after surgery from Screening 1 * Patients on at least 3 antihypertensive medications of different classes including diuretics 3. Those who meet the following blood pressure requirements: \[Screening 1\] * Office systolic blood pressure (SBP) ≥ 140 mmHg * Office diastolic blood pressure (SBP) ≥ 90 mmHg \[Screening 2\] * Office SBP ≥ 140 mmHg * Office DBP ≥ 90 mmHg * Daytime ASBP ≥ 135 mmHg 4. Those who have the ability and willingness to provide voluntary and written consent to participate in this clinical trial Exclusion Criteria: Subjects cannot be enrolled i