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
\< Study purpose \> The purpose of this single arm interventional study is to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic \< Background and Hypothesis \> The HyperQureTM RDN(Renal Denervation) System is developed to overcome the limitations of endovascular RDN using catheters; 1)incomplete renal denervation, 2) risk of intimal damage due to intravascular access, and 3) access limitations due to vascular anatomy and size The HyperQureTM RDN System is accessed through the adventitia where renal sympathetic nerves are mainly distributed. Since energy is transmitted by wrapping the blood vessel 360 degrees, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of intimal damage, and solve structural access problems caused by the anatomy and size of the renal blood vessel. \< Study plan \> Ten eligible adult men and women with resistant hypertension will be enrolled and will have laparoscopic RDN under general anesthesia. CTA(Computed Tomographic Angiogram), blood tests, office blood pressure, 24-hour ambulatory blood pressure and QOL will be monitored to evaluate the safety and initial efficacy for 12 months after RDN procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
The 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 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 vessel is 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 is also performed on the branch or accessory vessel confirmed to be suitable for the procedure by CTA.
Chonnam National University Hospital Hwasun Hospital
Jeonam, Chonnam Province, South Korea
RECRUITINGSeoul National University Bundang Hospital
Gyeonggi-do, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
Change in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Change in 24-h ASBP from baseline at 3 months post procedure
Time frame: from baseline to 3 months post procedure
Change in 24-h ASBP
Change in 24-h ASBP from baseline to 6, 12 months post procedure
Time frame: from baseline to 6, 12 months post procedure
Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)
Change in 24-h ADBP from baseline to 3, 6, 12 months post procedure
Time frame: from baseline to 3, 6, 12 months post procedure
Change in daytime ASBP and ADBP
Change in daytime ASBP and ADBP from baseline to 3, 6, 12 months post procedure
Time frame: from baseline to 3, 6, 12 months post procedure
Change in nighttime ASBP and ADBP
Change in nighttime ASBP and ADBP from baseline to 3, 6, 12 months post procedure
Time frame: from baseline to 3, 6, 12 months post procedure
Change in Office Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Change in office SBP and DBP from baseline to 1, 3, 6, 12 months post procedure
Time frame: from baseline to 1, 3, 6, 12 months post-procedure
Incidence of achieving target office SBP (SBP <140 mmHg)
Incidence of achieving target office SBP(SBP \<140mmHg) at 1, 3, 6, 12 months post procedure
Time frame: at 1, 3, 6, 12 months post-procedure
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Hanyang University Seoul Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGThe Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
RECRUITINGYonsei University Health System, Severance Hospital
Seoul, South Korea
RECRUITINGChange in EQ-5D from baseline
Change in EQ-5D from baseline at 3, 6, 12 months post procedure. EQ-5D-5L is a QOL(Quality of Life) evaluation tool. This includes a "Questionnaire of five dimensions" to evaluate mobility, self-care, usual activities, discomfort or pain and depression or anxiety scored from level 1 to 5 (lower level means a better outcome; ex. level 1 of Mobility is "I have no problems in walking about) and also includes "EQ VAS" to evaluate "YOUR HEALTH TODAY" and this scale is numbered from 0 to 100.
Time frame: at 3, 6, 12 months post procedure
Incidence and patterns of adverse events
Incidence and patterns of adverse events from baseline to 3 and 12 months post procedure
Time frame: from baseline to 3 and 12 months post procedure
Incidence of major adverse events (MAE)*
\* MAE * All deaths * End-stage renal disease * Severe embolism resulting in end-organ damage * Renal artery dissection requiring intervention * Renal artery perforation requiring intervention * Vascular complications * Hypertensive crisis requiring hospitalization (unless due to non-compliance with drugs or therapy) * Newly confirmed renal artery stenosis (\>70%)
Time frame: from baseline to 1, 3, 6 and 12 months post procedure
Incidence of each of the following acute/procedural adverse event
* Postoperative complications rated as grade 3 or higher according to the Clavien-Dindo classification * Severe embolism resulting in end-organ damage * Renal artery dissection requiring intervention * Renal artery perforation requiring intervention * Vascular complications * End-stage renal disease * Hypertensive crisis requiring hospitalization (unless due to non-compliance with drugs or therapy) * Decrease in eGFR (≥40%) * Newly confirmed myocardial infarction * Newly confirmed stroke * Renal artery reoperation/surgery * Major bleeding in thrombolysis in myocardial infarction (TIMI)\* \* Death due to intracranial hemorrhage, absolute decrease in hemoglobin ≥5 g/m or in hematocrit ≥15%, or bleeding occurring within 7 days of surgery * More than 50% reduction in serum creatinine compared to Screening 2 * Newly confirmed renal artery stenosis (\>70%)
Time frame: from baseline to 1 month post procedure
Incidence of each of the following adverse events
* All deaths * Newly confirmed renal artery stenosis (\>70%) * End-stage renal disease * Hypertensive crisis requiring hospitalization (unless due to non-compliance with drugs or therapy) * Decrease in eGFR (≥40%) * Newly confirmed myocardial infarction * Newly confirmed stroke * Renal artery reoperation/surgery * Major bleeding in thrombolysis in myocardial infarction (TIMI)\* \* Death due to intracranial hemorrhage, absolute decrease in hemoglobin ≥5 g/mL or in hematocrit ≥15%, and bleeding occurring within 7 days of surgery * More than 50% reduction in serum creatinine compared to Screening 2
Time frame: from baseline to 3, 6 and 12 months post procedure
Normal/Abnormal conversion rate of laboratory test results
Normal/Abnormal conversion rate of laboratory test results from baseline to 1, 3, 6 and 12 months post procedure
Time frame: from baseline to 1, 3, 6 and 12 months post procedure
Change in heart rate
Change in heart rate from baseline to 1, 3, 6 and 12 months post procedure
Time frame: from baseline to 1, 3, 6 and 12 months post procedure