REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2026-05-18

Brief Summary

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The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)

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Detailed Description

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There is unequivocal evidence for an important contribution of increased renal sympathetic nerve activity to cardiovascular (CV) morbidity and mortality in high risk patient cohorts with CKD, ESRD and HF. The availability of a highly effective catheter-based ultrasound device to selectively target renal nerves provides a potential unique opportunity to improve CV outcomes in these patients, a proposition that now needs to be tested in initial pilot trials and subsequent appropriately designed randomized controlled trials.

Conditions

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Chronic Kidney Diseases Heart Failure End Stage Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic Kidney Disease

Renal Denervation

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

Heart Failure

Renal Denervation

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

End stage renal disease

Renal Denervation

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

Interventions

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Renal Denervation

All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Both Male and female patients
* Ages between 18-75 years of age
* Individual is competent and willing to provide written, informed consent to participate in this clinical study with either

* CKD stage 3a/b or
* ESRD on stable renal replacement therapy or
* Mild to moderate heart failure with reduced ejection fraction

Exclusion Criteria

* Ineligible anatomy
* Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device.
* Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
* Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
* Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
* Individual has been admitted for inpatient hospitalization for decompensated HF in the previous month
* Female participants of childbearing potential must have a negative pregnancy test prior to treatment.
* Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
* Individual is currently enrolled in another investigational drug or device trial. Note: For the purpose of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
* Individual has a disease or condition (aside from CKD, ESRD, and HFrEF) that may limit their life expectancy to \< 1 year.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No