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

NCT02388087 | Unknown

• 1 other identifier: SHAM-ROX NMS
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Absence of loss of consciousness on tilt table testing

  Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention

  3 months

Secondary Outcomes (4)

• Time to first episode of syncope after randomised intervention

  3 months

• Number of syncopal episodes in the first 3 months after randomised intervention

  3 months

• Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding

  6 months

• Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding

  6 months

Other Outcomes (3)

• Heart rate variability following intervention as observed on 24 hour holter monitoring

  3 and 6 months

• Changes in echocardiographic parameters following intervention compared to baseline.

  3 and 6months

• Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline.

  3 and 6months

Study Arms (2)

ROX COUPLER

ACTIVE COMPARATOR

Iliac arterio-venous anastamosis created by insertion of ROX coupler device.

Device: ROX COUPLER

ROUTINE CARE

SHAM COMPARATOR

Right heart catheterisation and Routine care of Neurally mediated syncope.

Procedure: Right heart catheterisation and routine care

Interventions

ROX COUPLER DEVICE

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

ROX COUPLER

Right heart catheterisation and routine care PROCEDURE

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

ROUTINE CARE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention

You may not qualify if:

• Time to first episode of syncope after randomised intervention
• Number of syncopal episodes in the first 3 months after randomised intervention.
• Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
• Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding

Sponsors & Collaborators

• Eastbourne General Hospital: lead

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Neil Sulke, BSc, DM, FRCP

CONTACT

neil.sulke@esht.nhs.uk

Shunmugam Ragunath Shunmugam, MBBS, MRCP

CONTACT

r.shunmugam@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 24, 2015

Record last verified: 2015-03