Atrial Fibrillation Clinical Trial
Official title:
Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients
Verified date | July 2023 |
Source | MaineHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 209 |
Est. completion date | September 6, 2022 |
Est. primary completion date | September 6, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Pen Bay Medical Center | Rockport | Maine |
Lead Sponsor | Collaborator |
---|---|
Crystal Blake-Parlin | MaineHealth |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. |
12 months |
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