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
\<Study purpose\> The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM, laparoscopic(extravascular) renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1) prove the concept of complete ablation by Extravascular RDN and 2) develop a solid reference for a pivotal study \<Background and Hypothesis\> The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters; 1)incomplete renal denervation, 2) risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access, and 3) access limitations due to vascular anatomy and vessel size. The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopic(extravascular) approach . Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch and/or accessory vessels, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of endothelial damage, and resolve structural access limitations. \<Study plan\> Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascular(laparoscopic) RDN under general anesthesia and will have 36month follow up with various BP evaluations(24hABP, Office BP and Home BP) and CTA/DUS imaging scan evaluations
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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 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.
University of California Irvine
Orange, California, United States
RECRUITINGStanford Health Care
Stanford, California, United States
RECRUITINGUniversity of Florida College of Medicine
Gainesville, Florida, United States
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
Time frame: from baseline to 3 months post procedure
• 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).
Time frame: from baseline to1-month post-procedure
Change in 24-h ASBP
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
Time frame: from baseline to 6-, 12-, 24-, 36-months post procedure.
Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)
Measured by 24-hour ABPM
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure.
Change in daytime ASBP and ADBP
Measured by 24 hour ABPM
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure
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Henry Forth Health
Detroit, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGChange in nighttime ASBP and ADBP
Measured by 24 hour ABPM
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure
Change in Office Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Measured by Office BP device
Time frame: from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Change in Home Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Measured by Home BP device
Time frame: from baseline to 1-, 3-, 6-, 12-months post procedure
Incidence of achieving target office SBP (SBP <140 mmHg)
Number of achieving target office SBP measured by Office BP device
Time frame: from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Incidence of each of the following acute/procedural adverse event
* Procedural complication (≥grade 3) as per Clavien-Dindo classification. * Significant embolic event resulting in end-organ damage. * Renal artery perforation requiring intervention. * Renal artery dissection requiring intervention. * Vascular complications. * ESRD. * ≥40% decline in estimated glomerular filtration rate (eGFR). * New myocardial infarction. * New stroke. * Renal artery re-intervention. * Increase in serum creatine \>50% from Screening Visit 2. * Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol. * New renal artery stenosis \>70%, diagnosed by DUS and confirmed by computed tomography (CT) angiography or diagnosed/confirmed by CTA.
Time frame: from baseline to 1-month post-procedure
Incidence of each of the following chronic adverse event
* All-cause mortality. * ESRD (≥40% decline in eGFR). * New myocardial infarction. * New stroke. * Renal artery re-intervention. * Increase in serum creatine \>50% from Screening Visit 2. * Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol. * New renal artery stenosis \>70%, diagnosed by DUS and confirmed by CT angiography or diagnosed/confirmed by CTA
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post-procedure