Trial Outcomes & Findings for Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage (NCT NCT01721447)

Last Updated: 2019-08-20

Results Overview

Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

One Transesophageal Echocardiography, up to 1 hour

Results posted on

2019-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Echo Arm Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Echo Arm n=100 Participants Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	70 Participants n=5 Participants
Age, Continuous	69.9 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: One Transesophageal Echocardiography, up to 1 hour

Outcome measures

Outcome measures
Measure	Pre-Contrast n=100 Participants Standard trans-esophageal echocardiography imaging prior to injection of Optison contrast	Post-Contrast n=100 Participants Trans-esophageal echocardiography imaging following injection of Optison contrast
Percent Confidence in Assessment of Left Atrial Appendage Thrombus	55 Percentage of Confidence Standard Deviation 12.5	95 Percentage of Confidence Standard Deviation 7.5

SECONDARY outcome

Timeframe: One transesophageal echocardiography, up to 1 hour

Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent

Outcome measures

Outcome measures
Measure	Pre-Contrast n=100 Participants Standard trans-esophageal echocardiography imaging prior to injection of Optison contrast	Post-Contrast n=100 Participants Trans-esophageal echocardiography imaging following injection of Optison contrast
Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage	72 Percentage of Agreement	96 Percentage of Agreement

Adverse Events

Echo Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Echo Arm n=100 participants at risk Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Nervous system disorders Transient Ischemic Attack	1.0% 1/100 • Number of events 1 • 3 Months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brent Wilson

University of Utah Division of Cardiovascular Medicine

Phone: 801-585-2341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place