Trial Outcomes & Findings for Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients (NCT NCT04313296)

Last Updated: 2023-08-14

Results Overview

Left atrial global longitudinal strain as measured utilizing the TOMTECH - ARENA software program compared to duration of the maintenance of sinus rhythm following elective cardioversion. Time, in months, sinus rhythm was maintained.

Recruitment status

TERMINATED

Study phase

Target enrollment

209 participants

Primary outcome timeframe

12 months

Results posted on

2023-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Identified at PBMC(Pen Bay Medical Center) With a Documented Diagnosis of AF Patients identified at PBMC with a documented diagnosis of AF (Atrial Fibrillation) (at any point in time) and who have undergone any cardioversion. Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA): The historic echocardiograms from patients who meet the study inclusion criteria will be uploaded into this software, which was newly acquired by the PBMC Cardiology Department. MaineHealth Information Services are currently working with study staff to assure appropriate security compliance within the network. LA GLS has not been routinely collected previously from echocardiograms performed at PBMC because of a lack of such technology.
Overall Study STARTED	209
Overall Study COMPLETED	209
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Identified at PBMC With a Documented Diagnosis of AF n=209 Participants Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion. Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA): The historic echocardiograms from patients who meet the study inclusion criteria will be uploaded into this software, which was newly acquired by the PBMC Cardiology Department. MaineHealth Information Services are currently working with study staff to assure appropriate security compliance within the network. LA GLS has not been routinely collected previously from echocardiograms performed at PBMC because of a lack of such technology.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	159 Participants n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	207 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
Region of Enrollment United States	209 participants n=5 Participants
Patients Identified at PBMC with a documented diagnosis of AF	209 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Patients Identified at PBMC Who Underwent Cardioversion With a Diagnosis of AF n=209 Participants Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion. Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA): The historic echocardiograms from patients who meet the study inclusion criteria will be uploaded into this software, which was newly acquired by the PBMC Cardiology Department. MaineHealth Information Services are currently working with study staff to assure appropriate security compliance within the network. LA GLS has not been routinely collected previously from echocardiograms performed at PBMC because of a lack of such technology.
Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion Maintained SR for >6 months	85 participants
Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion Did not maintain SR for 6 months	124 participants

Adverse Events

Patients Identified at PBMC With a Documented Diagnosis of AF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Caroline Knight

Pen Bay Medical Center

Phone: 207-301-8959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place