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 range
22 Years – 80 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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
. 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)