Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
NCT ID: NCT04719637
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2021-08-24
2024-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PRDS-001
Renal denervation
PRDS-001 Renal Denervation Ultrasound System
Renal Denervation Ultrasound System
Interventions
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PRDS-001 Renal Denervation Ultrasound System
Renal Denervation Ultrasound System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m\^2 (estimation formula by Japanese Society of Nephrology)
* Patients with concomitant or previous autoimmune or inflammatory bowel disease
* Patients with a history of serious lung disease
* Patients with a history of heart transplantation or VAD \[ventricle-assist device\]
* Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained)
* Patients being treated for Parkinson's disease or Lewy body dementia
* 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
* Patients with persistent atrial fibrillation
* Patients using active implantable medical devices
* 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
* Female patients who are pregnant or breastfeeding
* Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test
18 Years
84 Years
ALL
No
Sponsors
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Otsuka Medical Devices Co., Ltd. Japan
INDUSTRY
Responsible Party
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Locations
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Osaka University Hospital
Osaka, , Japan
Countries
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Other Identifiers
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RDN-19-001
Identifier Type: -
Identifier Source: org_study_id
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