Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients

NCT04313296 | Terminated Results FDA Device

• 1 other identifier: Blake-ParlinTOMTEC
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients identified at PBMC with a documented diagnosis of AF

EXPERIMENTAL

Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion.

Device: Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)

Interventions

Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA) DEVICE

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.

Patients identified at PBMC with a documented diagnosis of AF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Crystal Blake-Parlin: lead
• MaineHealth: collaborator

Study Sites (1)

Pen Bay Medical Center

Rockport, Maine, 04856, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Caroline Knight
• Organization: Pen Bay Medical Center

caroline.knight@mainehealth.org

207-301-8959

Study Officials

• Crystal Blake-Parlin

  Pen Bay Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Supervisor-Lead Cardiac Ultrasound Sonographer

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: March 18, 2020
• Study Start: May 1, 2020
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)