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CompletedNCT02754349Updated Sep 7, 2016

Validation Study of Pulse Wave Velocity and Augmentation Index in Atrial Fibrillation

An interventional study of SphygmoCor version 7, AtCor Medical, Sydney, Australia in Atrial Fibrillation, sponsored by Onze Lieve Vrouw Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-07.

Sponsored by Onze Lieve Vrouw Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate the reliability of measurements of arterial stiffness (pulse wave velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and pulse pressure (PP)) in atrial fibrillation (AF). For this purpose 30 AF patients scheduled for electrical cardioversion will be included. PWV and PWA measurements will be carried out before and after cardioversion.

Read the detailed description

In recent years the role of arterial stiffness in the development of cardiovascular diseases has garnered attention. Indeed, arterial stiffness is now well accepted as one of the most important determinants of increasing systolic and pulse pressure thus playing a germane role in the risk of stroke and myocardial infarction. Longitudinal epidemiological studies have demonstrated the independent predictive value of arterial stiffness for cardiovascular events after adjustment for classical cardiovascular risk factors. Arterial stiffness is now a recognized intermediate endpoint for cardiovascular events. The pressure wave speed in large arteries is directly related to square root of the elastic modulus of the arterial wall (Moens-Korteweg Equation). Carotid-femoral PWV is considered the gold standard method for assessing aortic stiffness. The stiffness gradient along the aorta and central arteries, local arterial branchings and narrowing of the arterial lumen cause partial reflections of forward pressure waves traveling back to the central aorta. Forward and reflected pressure waves overlap, and the final amplitude and shape of the pulse pressure wave are determined by the phase timing of these component waves. In the aorta, forward and reflected waves are not in phase. In subjects with low PWV, reflected waves reach the central arteries during late-systole and diastole, increasing the aortic pressure in early diastole, which is physiologically advantageous. With increasing PWV, the reflected waves return earlier and impact on the central arteries during systole, thereby augmenting systolic and left ventricular pressure. This is why increasing PWV is accompanied by increasing AIx (defined as the difference between the second and first systolic pressure peak) and central PP. AIx and central PP depend on the speed of wave travel, the amplitude of reflected wave and the duration and pattern of ventricular ejection, especially with respect to change in heart rate and ventricular contractility. Where PWV is considered a direct measure of arterial stiffness, central PP and AIx are only indirect, surrogate measures. However, they provide additional information concerning wave reflections. Whether PWV, AIx and central PP measurements are influenced by the presence of AF is unknown. Studying AF patients before and after elective electrical cardioversion offers an appropriate setting to evaluate the effect of heart rate and rhytm on PWV, AIx and central PP. Patient specific confounding factors are minimized because each patient serves as its own control.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • pulse wave velocity
  • augmentation index
  • central pulse pressure
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 40 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Onze Lieve Vrouw Hospital is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • man or woman, age ≥18 years
  • signed written informed consent
  • atrial fibrillation or flutter
  • scheduled for elective electrical cardioversion

Exclusion criteria

Exclusion Criteria:

  • inability to understand the nature, scope and possible consequences of the study
  • clinical conditions that could hamper hemodynamic measurements (absence of femoral pulse, systolic blood pressure \< 90 mmHg)
  • presence of prosthetic material (grafts, stents or stent-grafts) in the aorta or femoral arteries
  • any condition precluding the execution of the cardioversion procedure
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Validation

    SphygmoCor version 7, AtCor Medical, Sydney, Australia

    Device: SphygmoCor version 7, AtCor Medical, Sydney, Australia

Interventions

  • DeviceSphygmoCor version 7, AtCor Medical, Sydney, Australia

    Pulse wave velocity, augmentation index and central blood pressure measurement with applanation tonometry before and after electrical cardioversion

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What researchers measure

Primary outcomes

  1. Pulse Wave Velocity (in meters per second) before and after cardioversion

    with assessment of agreement on the individual level and systematic bias using the group average before and after cardioversion

    Time frame: immediate

Secondary outcomes

  1. Augmentation Index (in percent) before and after cardioversion

    with assessment of agreement on the individual level and systematic bias using the group average before and after cardioversion.hemodynamic parameters obtained from pulse wave analysis (including AIx en central blood pressure)

    Time frame: immediate

  2. Central systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure (in mmHg) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion

    Time frame: immediate

  3. Heart rate (beats/min) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion.

    Time frame: immediate

07

Study locations

1 site
  • OLV Hospital
    Aalst, 9300, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2016
First posted
Apr 28, 2016
Start
Feb 2015
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Sep 7, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02754349
Lead sponsor
Onze Lieve Vrouw Hospital
Responsible party
Rogier Caluwe (Dr. Rogier Caluwé, MD, Onze Lieve Vrouw Hospital) — Principal investigator
First posted
Apr 28, 2016
Start date
Feb 2015
Primary completion
May 2016
Completion
May 2016
Last update
Sep 7, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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