NCT04719637Completed
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 16 Dec 2020
- Start date
- 24 Aug 2021
- Primary completion date
- 16 Feb 2022
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Diseases
- Heart failure
- NCT number
- NCT04719637
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 24 Aug 2021 to the primary completion date, 16 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant or previous autoimmune or inflammatory bowel disease
- Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained)
- Patients with a history of any severe cardiovascular event (myocardial infarction, coronary artery bypass graft surgery, acute heart failure requiring hospitalization) or severe cerebrovascular event (stroke, transient ischemic event, cerebrovascular accident, etc.) within 3 months before obtaining informed consent
Other illness
- Patients with a history of serious lung disease
- Patients with a history of heart transplantation or VAD \[ventricle-assist device\]
- Patients being treated for Parkinson's disease or Lewy body dementia
- Patients with coronary or carotid artery diseases who were deemed necessary by the principal investigator / sub investigator to undergo surgery or PCI (Percutaneous Coronary Intervention) within 6 months after obtaining informed consent
- Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media
Lab values
- Patients with type1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (HbA1c: ≥ 8%)
- Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m\^2 (estimation formula by Japanese Society of Nephrology)
Other
- Patients with persistent atrial fibrillation
- Patients using active implantable medical devices
- Female patients who are pregnant or breastfeeding
- Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test
Who the study is looking for
- Patients aged 18 years or older and younger than 85 years at the time of informed consent
- NYHA (New York Heart Association) class II-III
- More than 6 weeks have passed since onset of acute heart failure or acute exacerbation of chronic heart failure
- Washout rate of MIBG \[3 (meta)-iodobenzylguanidine\] scintigraphy-cardiac is more than 35%
- Patients having continued treatment of heart failure with the same dosage and administration for 4 weeks before obtaining informed consent
Age in the registry: 18 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Osaka University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.