HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
Aged ≥22 and ≤80 years old at time of enrollment (consent).
Diagnosed with resistant hypertension.
Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
Myocardial infarction within 3 months of enrollment.
Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
Single group
HyperQureTM Renal Denervation (RDN) System:
DeviceThe HyperQure RDN System consists of a Generator that generates RF energy and a Laparoscopic Instrument that delivers the RF energy generated by the generator to the treatment area. Through a extravascular(laparoscopic) approach, the renal artery is accessed through the retroperitoneum, which is the closest path to the renal artery. After wrapping 360 degrees of renal artery, RDN is performed as per the preset parameters of 50 degrees and 70 seconds. The target blood vessels will be planned by CTA before the procedure, and the proximal and distal areas of the right and left main renal artery are treated once at a distance of at least 3 mm respectively, and RDN will be also performed on the branch or accessory vessels confirmed to be suitable for the procedure by CTA.
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
• Incidence of major adverse events (MAE). Defined as a composite of the following events, through 1-month post-procedure
* All-cause mortality. * End-stage renal disease (ESRD). * Significant embolic event resulting in end-organ damage * Renal artery perforation requiring intervention. * Renal artery dissection requiring intervention. * Vascular complications. * Injury to surrounding structures (inc. vasculature structure, the ureters, colon and or other intraabdominal and/or retroperitoneal structures). * Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol. * New renal artery stenosis \>70%, as diagnosed by DUS and confirmed by Computed Tomography Angiogram (CTA) or diagnosed/confirmed by renal CTA. * Prolongation of hospitalization after the index intervention for device or procedural related issues. * Major bleeding (bleeding Type 3a or higher according to the Bleeding Academic Research Consortium \[BARC\]2; overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding).
Change in 24-h ASBP
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)
Measured by 24-hour ABPM
Change in daytime ASBP and ADBP
Measured by 24 hour ABPM
Change in nighttime ASBP and ADBP
Measured by 24 hour ABPM
Change in antihypertensive medication usage
Medication change(number, type, dose) will be evaluated by drug surveillance diary and blood/urine drug testing
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