Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
NCT Number: NCT06526858
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Resistant Hypertension
Interventions: DEVICE: HyperQureTM Renal Denervation (RDN) System:
Sponsor: DeepQure Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-29
Completion Date: 2028-05-18
Locations: University of Arizona Department of Urology, Tucson, Arizona, 85719, United States|University of California Irvine, Orange, California, 92868, United States|Stanford Health Care, Stanford, California, 94305, United States|Emory University Medical Center, Atlanta, Georgia, 30303, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
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

Primary Outcome Measures: Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP), Measure by 24-hour ambulatory blood pressure monitoring(ABPM), 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)., from baseline to1-month post-procedure
Secondary Outcome Measures: Change in 24-h ASBP, Measure by 24-hour ambulatory blood pressure monitoring(ABPM), from baseline to 6-, 12-, 24-, 36-months post procedure.|Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP), Measured by 24-hour ABPM, from baseline to 3-, 6-, 12-, 24-, 36-months post procedure.|Change in daytime ASBP and ADBP, Measured by 24 hour ABPM, from baseline to 3-, 6-, 12-, 24-, 36-months post procedure|Change in nighttime ASBP and ADBP, Measured by 24 hour ABPM, 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, 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, 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, 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., 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, from baseline to 3-, 6-, 12-, 24-, 36-months post-procedure
Other Outcome Measures: Change in antihypertensive medication usage, Medication change(number, type, dose) will be evaluated by drug surveillance diary and blood/urine drug testing, from baseline up to 36-months post procedure