Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655443
Status:
TERMINATED
Last Update Posted:
2021-07-14
First Post:
2020-11-30
Brief Title:
Risk Factors That Contribute to the Maintenance of Sinus Rhythm
Sponsor:
Danbury Hospital
Organization:
Danbury Hospital
Study Overview
Official Title:
Risk Factors That Contribute to the Maintenance of Sinus Rhythm A Prospective Study to Create a Prediction Model for Atrial Fibrillation Patients to Maintain Sinus Rhythm
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Afib
Brief Summary:
This is a prospective clinical research study The objective of this study is to evaluate if clinical risk factors as well as structural features on echocardiography affect the maintenance of sinus rhythm after electrical cardioversion at 30 days The investigators anticipate 140 patients to be enrolled in the study
Detailed Description:
Atrial fibrillation is the most commonly diagnosed arrhythmia in the United States A systematic review of worldwide population-based studies estimated that approximately 33 million people were diagnosed with atrial fibrillation in 2010 The prevalence of atrial fibrillation in the United States increases with advancing age Approximately 1 of patients with atrial fibrillation are under 60 years of age whereas more than one-third are over 80 years of age
Although atrial fibrillation is commonly diagnosed and continues to have increased incidence in the country patients continue to be admitted to the hospital for worsening symptoms of chest pain shortness of breath and palpitations Long-term complications of atrial fibrillation include cardiomyopathy cerebrovascular events thromboembolic events and death
Many medications have been established to convert patients from atrial fibrillation to normal sinus rhythm however procedures of cardioversion and ablation have also proven to be effective A study the AFFIRM trial published in the New England Journal of Medicine in 2002 discussed the benefit of converting patients to sinus rhythm versus keeping patients in atrial fibrillation however making sure their heart rates were well-controlled This study did not demonstrate a significant difference in death ischemic stroke or major bleeding in both treatment arms suggesting there is no benefit of converting patients from atrial fibrillation to normal sinus rhythm However with increasing health costs occurring around the country every effort should be made to help improve patient symptoms and avoid unnecessary hospitalizations A study published in the Journal of American College of Cardiology in 2004 Effect of rate or rhythm control on quality of life in persistent atrial fibrillation Results from the Rate Control Versus Electrical Cardioversion RACE study concluded that the quality of life was impaired in patients with atrial fibrillation Another study published in 2012 Economic Burden of Atrial Fibrillation Implications for Intervention reported total costs of atrial fibrillation care in the United States to be estimated to be 665 billion per year
Our study is designed to look at patients with atrial fibrillation who underwent electrical cardioversion to restore sinus rhythm and create a prediction model to identify specific risk factors which may contribute to persistent atrial fibrillation
Prediction models have been established in regards to maintaining sinus rhythm including the Hatch Score which examined risk factors of hypertension history of TIA or stroke chronic obstructive pulmonary disease and heart failure that predisposed patients to persistent atrial fibrillation Another score established was the LADS score which observed risk factors of left atrial diameter age history of stroke and smoking status as predictors of persistent atrial fibrillation The purpose of our study is to create a new prediction model using clinical and echocardiographic parameters to determine if these factors will predict persistent atrial fibrillation after electrical cardioversion Transesophageal echocardiographic parameters include imaging of the left atrial appendage LAA and calculating the LAA ejection fraction LAAEF by 3D or biplane Simpson method based on image quality and using pulse-wave Doppler to calculate the LAA exit velocity and SD ratio across the pulmonic vein Transthoracic echocardiographic parameters include estimated pulmonary arterial pressure PASP using tricuspid regurgitation TR jet velocity left atrial volume index LAVi left ventricular LV size LV hypertrophy LVH and left ventricular ejection fraction LVEF
Although atrial fibrillation is commonly diagnosed and continues to have increased incidence in the country patients continue to be admitted to the hospital for worsening symptoms of chest pain shortness of breath and palpitations Long-term complications of atrial fibrillation include cardiomyopathy cerebrovascular events thromboembolic events and death
Many medications have been established to convert patients from atrial fibrillation to normal sinus rhythm however procedures of cardioversion and ablation have also proven to be effective A study the AFFIRM trial published in the New England Journal of Medicine in 2002 discussed the benefit of converting patients to sinus rhythm versus keeping patients in atrial fibrillation however making sure their heart rates were well-controlled This study did not demonstrate a significant difference in death ischemic stroke or major bleeding in both treatment arms suggesting there is no benefit of converting patients from atrial fibrillation to normal sinus rhythm However with increasing health costs occurring around the country every effort should be made to help improve patient symptoms and avoid unnecessary hospitalizations A study published in the Journal of American College of Cardiology in 2004 Effect of rate or rhythm control on quality of life in persistent atrial fibrillation Results from the Rate Control Versus Electrical Cardioversion RACE study concluded that the quality of life was impaired in patients with atrial fibrillation Another study published in 2012 Economic Burden of Atrial Fibrillation Implications for Intervention reported total costs of atrial fibrillation care in the United States to be estimated to be 665 billion per year
Our study is designed to look at patients with atrial fibrillation who underwent electrical cardioversion to restore sinus rhythm and create a prediction model to identify specific risk factors which may contribute to persistent atrial fibrillation
Prediction models have been established in regards to maintaining sinus rhythm including the Hatch Score which examined risk factors of hypertension history of TIA or stroke chronic obstructive pulmonary disease and heart failure that predisposed patients to persistent atrial fibrillation Another score established was the LADS score which observed risk factors of left atrial diameter age history of stroke and smoking status as predictors of persistent atrial fibrillation The purpose of our study is to create a new prediction model using clinical and echocardiographic parameters to determine if these factors will predict persistent atrial fibrillation after electrical cardioversion Transesophageal echocardiographic parameters include imaging of the left atrial appendage LAA and calculating the LAA ejection fraction LAAEF by 3D or biplane Simpson method based on image quality and using pulse-wave Doppler to calculate the LAA exit velocity and SD ratio across the pulmonic vein Transthoracic echocardiographic parameters include estimated pulmonary arterial pressure PASP using tricuspid regurgitation TR jet velocity left atrial volume index LAVi left ventricular LV size LV hypertrophy LVH and left ventricular ejection fraction LVEF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None