Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in P… (NCT06526858) | Clinical Trial Compass
RecruitingNot Applicable
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
United States15 participantsStarted 2024-11-21
Plain-language 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
Who can participate
Age range22 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion criteria
✕. Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
✕. Has one or more of the following conditions:
✕. 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
✕. Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
✕. Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded
What they're measuring
1
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Timeframe: from baseline to 3 months post procedure
2
• Incidence of major adverse events (MAE). Defined as a composite of the following events, through 1-month post-procedure
✕. Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)