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Renal Nerves Stimulation Study

NCT02496117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-05-06

No results posted yet for this study

Summary

Study design: Investigator initiated, single centre, feasibility study

Main objectives are twofold:

1. To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
2. To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.

Study population: 40 patients (18 - 80 yr old)

Conditions

Interventions

PROCEDURE

Electrical mapping, nerve stimulation checked renal denervation procedure

PROCEDURE

Electrial mapping, nerve stimulation guided renal denervation procedure

Sponsors & Collaborators

  • Diagram B.V.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-14
Primary Completion
2019-07-04
Completion
2019-07-04

Countries

  • Netherlands

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 NCT02496117 on ClinicalTrials.gov