Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorDeepQure Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HyperQureTM Renal Denervation (RDN) System:

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators