RecruitingNot Applicable

FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension

China180 participantsStarted 2023-03-31

Plain-language summary

To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.

Who can participate

Age range

18 Years – 70 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.

Exclusion criteria

. Renal artery diameter \<4mm or treatment length \<20mm;
. Renal artery stenosis \>50% or renal aneurysm on either side;
. A history of renal artery intervention, including balloon angioplasty or stenting or RDN;
. Primary pulmonary hypertension (moderate to severe);
. Type I diabetes;
. History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
. History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
. Factors that interfere with blood pressure measurement in any case (eg, patients with severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);

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

24-hour ambulatory mean systolic blood pressure reduction

Timeframe: Baseline to 6 months

The incidence of Major Adverse Events (MAE)

Timeframe: Baseline to 1 month

Trial details

NCT IDNCT05590871

SponsorShanghai Hongdian Medical CO., LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Yuehui Yin, MD

+86 13508335502 Yinyh@hospital.cqmu.edu.cn

View on ClinicalTrials.gov More Hypertension trials