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Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients

Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04313296
Enrollment
209
Registered
2020-03-18
Start date
2020-05-01
Completion date
2022-09-06
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

Atrial fibrillation (AF) is the most common heart rhythm disorder seen in clinical practice, with an estimated 2.7-6.1 million people in the U.S. affected by the disorder \[1\]. Previous studies have demonstrated that left atrial volume is a predictive measure of incident atrial fibrillation \[2\]. This study aims to add to the literature by investigating predictive measures of left atrial global longitudinal strain (LA GLS) that would be suggestive of maintenance of normal sinus rhythm post cardioversion. If the investigators could gain insight on the connection between LA GLS and cardioversion among patients with atrial fibrillation, the investigators could potentially help the clinical management of patients pre/post cardioversion, and potentially change poor outcomes.

Detailed description

Atrial fibrillation (AF) is a heart rhythm disorder in which the normal beating in the upper chambers of the heart is irregular, leading to poor blood flow to the lower chambers. Risk factors include older age, high blood pressure, obesity, European ancestry, diabetes, heart failure, ischemic heart disease, hyperthyroidism, chronic kidney disease, heavy alcohol use, and enlarged heart chambers on the left side \[3\]. AF increases a person's risk for stroke and contributes to an estimated 130,000 deaths each year \[1\]. Treatment generally includes medication, surgery, and/or healthy lifestyle changes \[1\]. Electrical cardioversion, in which the patient must undergo sedation or general anesthesia, is also used to convert patients with persistent AF to normal sinus rhythm. Electrical cardioversion has been associated with a high initial success rate of 68-98% \[4\], but long-term maintenance of sinus rhythm has proved challenging \[5\]. Due to the potential risks incurred to the patient, it is important to understand which patients are good candidates for cardioversion therapy. A review article describes that duration of AF, sex, age, weight smoking status, number of shocks at cardioversion, post-ablation procedure, medications, hypertension, diabetes, Chronic Obstructive Pulmonary Disease (COPD), obstructive sleep apnea, renal impairment, hyperthyroidism, coronary artery disease, congestive heart failure, left systolic dysfunction, left diastolic dysfunction, left ventricular hypertrophy, valvular heart disease, and left atrial size have each been found to be associated with maintenance of sinus rhythm \[6\]. Echocardiography has been increasing used in understanding the cardiac structure and risk of stroke among patients with AF, with left atrial size, left ventricular wall thickness, and left ventricular dysfunction recognized as independent predictors of AF \[7\]. Increasing evidence supports that the left atrial strain measurements can be a predictor of outcomes among AF patients, including stroke and AF recurrence after catheter ablation \[8\], \[9\]. The investigators aim to further explore left atrial strain measurements, including left atrial global longitudinal strain (LA GLS), as predictors of maintenance of normal sinus rhythm post- cardioversion. It is anticipated that a lower LA GLS will predict AF recurrence. To do this, the investigators will study patients with AF at Pen Bay Medical Center who have undergone cardioversion, measuring their LA GLS pre-cardioversion, and assess maintenance of sinus rhythm 6 months post-cardioversion. It is anticipated that this study will confirm LA GLS as a marker for maintenance of sinus rhythm post-cardioversion.

Interventions

DEVICEUnique 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.

Sponsors

MaineHealth
CollaboratorOTHER
Crystal Blake-Parlin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a retrospective and prospective cohort study of patients with atrial fibrillation (AF) identified at Pen Bay Medical Center (PBMC). Patients will be identified for inclusion in the study based on a previous documented diagnosis of AF, have a documented echocardiogram, and have undergone electrical cardioversion, with a study enrollment goal of 150 patients.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* • Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion. * The patient would also need to have had an echocardiogram within six months pre-cardioversion (performed for any reason) with a well visualized atrial roof in order to perform the measurements accurately using the TOMTEC-ARENA software.

Exclusion criteria

* • Patients with a mitral regurgitation greater than moderate (effective regurgitant orifice \>= .2 mm2) * Patients with post-surgical valve repair or replacement, if the procedure was done with a thoracotomy * Any patient how has had any cardiac surgery requiring a thoracotomy

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion12 monthsLeft 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Patients Identified at PBMC With a Documented Diagnosis of AF
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.
209
Total209

Baseline characteristics

CharacteristicPatients Identified at PBMC With a Documented Diagnosis of AF
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
159 Participants
Age, Categorical
Between 18 and 65 years
50 Participants
Patients Identified at PBMC with a documented diagnosis of AF209 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
207 Participants
Region of Enrollment
United States
209 participants
Sex: Female, Male
Female
97 Participants
Sex: Female, Male
Male
112 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion

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.

Time frame: 12 months

ArmMeasureGroupValue (NUMBER)
Patients Identified at PBMC Who Underwent Cardioversion With a Diagnosis of AFNumber of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After CardioversionMaintained SR for >6 months85 participants
Patients Identified at PBMC Who Underwent Cardioversion With a Diagnosis of AFNumber of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After CardioversionDid not maintain SR for 6 months124 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026