Risk Factors That Contribute to the Maintenance of Sinus Rhythm

Atrial Fibrillation Clinical Trial

— Afib  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04655443
• Other study ID #: 17-601
• Status: Terminated
• Start date: August 29, 2017
• Est. completion date: February 3, 2021

Study information

• Verified date: July 2021
• Source: Danbury Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 $6.65 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 S/D 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Documented atrial fibrillation by electrocardiogram (ECG)

• Patients undergoing electrical cardioversion for atrial fibrillation

• Patients with a baseline transthoracic echocardiography within 1 month prior to the cardioversion

Exclusion Criteria:

• Patients who did not convert to normal sinus rhythm after electrical cardioversion

• Patients who are found to have a LAA thrombus on TEE

• Patients who do not have a follow up ECG

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Standard Care
Standard cardiovascular care

Locations

Country	Name	City	State
United States	Danbury Hospital	Danbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Danbury Hospital

Country where clinical trial is conducted

United States, 

References & Publications (10)

Akdemir B, Altekin RE, Küçük M, Yanikoglu A, Karakas MS, Aktas A, Demir I, Ermis C. The significance of the left atrial volume index in cardioversion success and its relationship with recurrence in patients with non-valvular atrial fibrillation subjected — View Citation

Antonielli E, Pizzuti A, Pálinkás A, Tanga M, Gruber N, Michelassi C, Varga A, Bonzano A, Gandolfo N, Halmai L, Bassignana A, Imran MB, Delnevo F, Csanády M, Picano E. Clinical value of left atrial appendage flow for prediction of long-term sinus rhythm m — View Citation

Ecker V, Knoery C, Rushworth G, Rudd I, Ortner A, Begley D, Leslie SJ. A review of factors associated with maintenance of sinus rhythm after elective electrical cardioversion for atrial fibrillation. Clin Cardiol. 2018 Jun;41(6):862-870. doi: 10.1002/clc. — View Citation

European Heart Rhythm Association; Heart Rhythm Society, Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anders — View Citation

Gilbert KA, Hogarth AJ, MacDonald W, Lewis NT, Tan LB, Tayebjee MH. Restoration of sinus rhythm results in early and late improvements in the functional reserve of the heart following direct current cardioversion of persistent AF: FRESH-AF. Int J Cardiol. — View Citation

January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the manageme — View Citation

Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):313-20. doi: 10.1161/CIRCOUTCOMES.110.958165. Epu — View Citation

Malik S, Hicks WJ, Schultz L, Penstone P, Gardner J, Katramados AM, Russman AN, Mitsias P, Silver B. Development of a scoring system for atrial fibrillation in acute stroke and transient ischemic attack patients: the LADS scoring system. J Neurol Sci. 201 — View Citation

Vlachos K, Letsas KP, Korantzopoulos P, Liu T, Georgopoulos S, Bakalakos A, Karamichalakis N, Xydonas S, Efremidis M, Sideris A. Prediction of atrial fibrillation development and progression: Current perspectives. World J Cardiol. 2016 Mar 26;8(3):267-76. — View Citation

Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transthoracic Echocardiography and Transesophageal Echocardiography findings	Left ventricular ejection fraction, left ventricular size, left ventricular hypertrophy, left atrial volume index, mitral valve early diastolic inflow velocity E, mitral valve tissue Doppler velocity e', E/e' ratio and pulmonary arterial pressure will be collected from transthoracic echocardiography findings in medical record. Left atrial size, left atrial appendage ejection fraction, left atrial appendage exit velocity, pulmonary venous flow with S/D ratio, and presence of spontaneous echo contrast will be collected from transesophageal echocardiography findings in medical record. Transthoracic Echocardiography and Transesophageal Echocardiography findings between participants that maintained sinus rhythm and participants that developed persistent atrial fibrillation will be compared to create a prediction model to identify specific risk factors, which may contribute to persistent atrial fibrillation.	30 days post electrical cardioversion
Secondary	Clinical risk factors	History of stroke/transient ischemic attack, hypertension, diabetes mellitus, congestive heart failure, coronary artery disease, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, hyperthyroidism, obesity, tobacco use, alcohol use, and home medications will be collected from medical record.	30 days post electrical cardioversion