CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Supine VM VAD +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03298880
NCT03298880N/ACompleted
CompareCT.gov

Testing of a Valsalva Assist Device (VAD) to Assess Effects on Vagal Tone and Strain Pressures Achieved Compared to a Standard Manometer in Healthy Volunteers Performing Standard and Modified Valsalva Manoeuvres.

University of Exeter·interventional·Posted Oct 2, 2017·Updated Jun 10, 2021

In Brief

A clinical study evaluating Supine VM VAD, Supine VAD manometer, and 2 other interventions for SVT and Vagal Bradycardia. Completed, enrolled 75 participants across 1 site.

Detailed Summary

A prototype for a Valsalva Assist Device (VAD), which provides resistance to exhalation, has been developed and is ready for testing in healthy volunteers. There is a need to ensure the device can deliver the required strain and evaluate the physiological response (lowered heart rate) when used to deliver a Valsalva manoeuvre (VM) with and without postural modification.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSVT, Vagal Bradycardia
CountriesUnited Kingdom
CollaboratorsRoyal Devon and Exeter NHS Foundation Trust

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 2, 2017
Enrollment StartNov 1, 2017
Primary CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.8 years ago

Interventions

Supine VM VADdevice

Valsalva strain delivered using VAD

Supine VAD manometerdevice

supine Valsalva strain delivered using manometer

Modified VM VADother

modified VM using VAD

Modified VM Manonmeterother

Postural modified position VM using manometer