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The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study

NCT02388087 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-03-24

No results posted yet for this study

Summary

The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.

Conditions

  • Neurally Mediated Syncope

Interventions

DEVICE

ROX COUPLER

ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.

PROCEDURE

Right heart catheterisation and routine care

Participants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion.

Sponsors & Collaborators

  • Eastbourne General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-08-31
Completion
2016-12-31

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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 NCT02388087 on ClinicalTrials.gov