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
DeepQure Inc.
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
Description
\<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)inc…
Eligibility
- Age range
- 22–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects are eligible to participate if all of the following criteria are met: 1. Aged ≥22 and ≤80 years old at time of enrollment (consent). 2. Diagnosed with resistant hypertension. 3. 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. 4. Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2. 5. Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate i…
Interventions
- DeviceHyperQureTM Renal Denervation (RDN) System:
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.
Locations (5)
- University of California IrvineOrange, California
- Stanford Health CareStanford, California
- University of Florida College of MedicineGainesville, Florida
- Henry Forth HealthDetroit, Michigan
- Mayo ClinicRochester, Minnesota