Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure

Otsuka Medical Devices

Status

Completed

Conditions

Chronic Heart Failure

Treatments

Device: PRDS-001 Renal Denervation Ultrasound System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04719637

RDN-19-001

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

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

Exclusion Criteria :

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)
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