Neurally Mediated SyncopeSHAM-ROX NMSNCT02388087
The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
A study testing ROX COUPLER and Right heart catheterisation and routine care in people with Neurally Mediated Syncope, run by East Sussex Healthcare NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurally Mediated Syncope
- What is being tested?
- ROX COUPLER and Right heart catheterisation and routine care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Neil Sulke, BSc, DM, FRCP contact
Shunmugam Ragunath Shunmugam, MBBS, MRCP contact
About this study
The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.
Read the detailed description
Neurally mediated syncope (NMS) is a debilitating condition, with no proven therapeutic measures. The ROX coupler is a device used to create an Iliac arterio-venous anastamosis which allows a shunt of 0.8 litres per minute. The haemodynamic changes following creation of an arterio-venous anastomosis at the iliac level leads to an increase in cardiac preload, reversing finding thought to induce NMS.
This a randomised controlled study to evaluate the effect of Iliac arterio-venous anastamosis in patients with neurally mediated syncope. The Head up tilt test is used as an objective measure to evaluate the effect of the arterio-venous anastamosis in patients with NMS. Participants with tilt test proven NMS will be eligible for the study ( if they satisfy all other eligibility criteria). Participants will be randomised to ROX coupler intervention or standard therapy. The primary outcome measure will be absence of loss consciousness on tilt table testing at 3 months post intervention.
- Conditions
- Neurally Mediated Syncope
- Being tested
- ROX COUPLER, Right heart catheterisation and routine care
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROX COUPLERDevice
ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.
Right heart catheterisation and routine careProcedure or surgery
Participants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion.
| Study group | Role | What they receive |
|---|---|---|
| ROX COUPLER | Active comparator | Iliac arterio-venous anastamosis created by insertion of ROX coupler device. Receives: Device: ROX COUPLER |
| ROUTINE CARE | Sham comparator | Right heart catheterisation and Routine care of Neurally mediated syncope. Receives: Procedure: Right heart catheterisation and routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Time to first episode of syncope after randomised intervention
Measured: 3 months
Number of syncopal episodes in the first 3 months after randomised intervention
Measured: 3 months
Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
Measured: 6 months
Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurally Mediated SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Sulke, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388087
- Sponsor's protocol ID
- SHAM-ROX NMS
- Acronym
- SHAM-ROX NMS
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
- ClinicalTrials.gov ID
- NCT02388087
- Acronym / sponsor ID
- SHAM-ROX NMS / SHAM-ROX NMS
- Conditions
- Neurally Mediated Syncope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.
Detailed description
Neurally mediated syncope (NMS) is a debilitating condition, with no proven therapeutic measures. The ROX coupler is a device used to create an Iliac arterio-venous anastamosis which allows a shunt of 0.8 litres per minute. The haemodynamic changes following creation of an arterio-venous anastomosis at the iliac level leads to an increase in cardiac preload, reversing finding thought to induce NMS.
This a randomised controlled study to evaluate the effect of Iliac arterio-venous anastamosis in patients with neurally mediated syncope. The Head up tilt test is used as an objective measure to evaluate the effect of the arterio-venous anastamosis in patients with NMS. Participants with tilt test proven NMS will be eligible for the study ( if they satisfy all other eligibility criteria). Participants will be randomised to ROX coupler intervention or standard therapy. The primary outcome measure will be absence of loss consciousness on tilt table testing at 3 months post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROX COUPLER | Active comparator | Device: ROX COUPLERIliac arterio-venous anastamosis created by insertion of ROX coupler device. |
| ROUTINE CARE | Sham comparator | Procedure: Right heart catheterisation and routine careRight heart catheterisation and Routine care of Neurally mediated syncope. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROX COUPLERROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation. | Device | ROX COUPLER |
| Right heart catheterisation and routine careParticipants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion. | Procedure or surgery | ROUTINE CARE |
Primary outcome
Absence of loss of consciousness on tilt table testing
Time frame: 3 months
Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention
4 secondary outcomes
Time to first episode of syncope after randomised intervention
Time frame: 3 months
Number of syncopal episodes in the first 3 months after randomised intervention
Time frame: 3 months
Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
Time frame: 6 months
Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Sulke, BSc, DM, FRCP contact
Shunmugam Ragunath Shunmugam, MBBS, MRCP contact
Questions about this trial
What is this clinical trial studying?
A study testing ROX COUPLER and Right heart catheterisation and routine care in people with Neurally Mediated Syncope, run by East Sussex Healthcare NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil Sulke, BSc, DM, FRCP (neil.sulke@esht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of loss of consciousness on tilt table testing (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.