NCT02754349

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

March 28, 2016

Last Update Submit

September 6, 2016

Conditions

Atrial Fibrillation

Keywords

pulse wave velocityaugmentation indexcentral pulse pressure

Outcome Measures

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

    immediate

Secondary Outcomes (3)

  • Augmentation Index (in percent) before and after cardioversion

    immediate

  • 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

    immediate

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

    immediate

Study Arms (1)

Validation

EXPERIMENTAL

SphygmoCor version 7, AtCor Medical, Sydney, Australia

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

Interventions

SphygmoCor version 7, AtCor Medical, Sydney, AustraliaDEVICE

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

Validation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Rogier Caluwé, MD

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 28, 2016

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)