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Multi-Organ Denervation With the iRF System to RedUce Sympathetic Drive

NCT04917393 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-06-21

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control.

Conditions

Interventions

DEVICE

iRF System Multi-organ Denervation

If assigned to the treatment arm, subjects will remain blinded and recieve angiography prior to catheter based RF ablation to circumferentially disrupt the sympathetic nerves surrounding the target arteries

OTHER

Control Procedure

If assigned to the control group, subjects will remain blinded and recieve angiography of the target arteries prior to sheath removal.

Sponsors & Collaborators

  • Metavention

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2022-10-01
Completion
2023-10-01

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917393 on ClinicalTrials.gov