Atrial FibrillationAfibNCT04655443
Risk Factors That Contribute to the Maintenance of Sinus Rhythm
An observational study of Atrial Fibrillation, run by Danbury Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 3 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing electrical cardioversion for atrial fibrillation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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 $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).
- Conditions
- Atrial Fibrillation
- Being tested
- Standard Care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Standard cardiovascular care
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Patients will be scheduled for an electrocardiogram thirty days after their electrical cardioversion. Based on the electrocardiogram result, patients that maintained sinus rhythm will be assigned to "Control". Receives: Other: Standard Care | |
| Afib Group | Patients will be scheduled for an electrocardiogram thirty days after their electrical cardioversion. Based on the electrocardiogram result, patients that developed persistent atrial fibrillation will be assigned to "Afib". Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post electrical cardioversion
Secondary outcomes (1)
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.
Measured: 30 days post electrical cardioversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start29 Aug 2017
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Why it stopped: due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ira Galin, MD, Principal investigator, Danbury Hospital, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655443
- Sponsor's protocol ID
- 17-601
- Acronym
- Afib
- Status last verified
- Jul 2021
- First submitted
- 30 Nov 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.
PubMed 24682347Vlachos 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. doi: 10.4330/wjc.v8.i3.267.
PubMed 27022458Wyse 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 control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.
PubMed 12466506Kim 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. Epub 2011 May 3.
PubMed 21540439Gilbert 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. 2015 Nov 15;199:121-5. doi: 10.1016/j.ijcard.2015.07.020. Epub 2015 Jul 11.
PubMed 26188832Ecker 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.22931. Epub 2018 Jun 7.
PubMed 29878481Malik 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. 2011 Feb 15;301(1-2):27-30. doi: 10.1016/j.jns.2010.11.011. Epub 2010 Dec 4.
PubMed 21130468European Heart Rhythm Association; Heart Rhythm Society; Fuster V, Ryden 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, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. doi: 10.1016/j.jacc.2006.07.009. No abstract available.
PubMed 16904574Akdemir B, Altekin RE, Kucuk 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 to electrical cardioversion: a study on diagnostic accuracy. Anadolu Kardiyol Derg. 2013 Feb;13(1):18-25. doi: 10.5152/akd.2013.003. Epub 2012 Oct 12.
PubMed 23070632Antonielli E, Pizzuti A, Palinkas A, Tanga M, Gruber N, Michelassi C, Varga A, Bonzano A, Gandolfo N, Halmai L, Bassignana A, Imran MB, Delnevo F, Csanady M, Picano E. Clinical value of left atrial appendage flow for prediction of long-term sinus rhythm maintenance in patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2002 May 1;39(9):1443-9. doi: 10.1016/s0735-1097(02)01800-4.
PubMed 11985905
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04655443
- Acronym / sponsor ID
- Afib / 17-601
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to COVID-19
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Danbury HospitalUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 $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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Standard CarePatients will be scheduled for an electrocardiogram thirty days after their electrical cardioversion. Based on the electrocardiogram result, patients that maintained sinus rhythm will be assigned to "Control". |
| Afib Group | – | Other: Standard CarePatients will be scheduled for an electrocardiogram thirty days after their electrical cardioversion. Based on the electrocardiogram result, patients that developed persistent atrial fibrillation will be assigned to "Afib". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing electrical cardioversion for atrial fibrillation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareStandard cardiovascular care | Other | Afib Group, Control Group |
Primary outcome
Transthoracic Echocardiography and Transesophageal Echocardiography findings
Time frame: 30 days post electrical cardioversion
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.
1 secondary outcome
Clinical risk factors
Time frame: 30 days post electrical cardioversion
Results and safety
The study was stopped early (reason given: due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Results publication: PubMed 24682347January 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 management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.
- Results publication: PubMed 27022458Vlachos 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. doi: 10.4330/wjc.v8.i3.267.
- Results publication: PubMed 12466506Wyse 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 control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.
- Results publication: PubMed 21540439Kim 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. Epub 2011 May 3.
- Results publication: PubMed 26188832Gilbert 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. 2015 Nov 15;199:121-5. doi: 10.1016/j.ijcard.2015.07.020. Epub 2015 Jul 11.
- Results publication: PubMed 29878481Ecker 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.22931. Epub 2018 Jun 7.
- Results publication: PubMed 21130468Malik 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. 2011 Feb 15;301(1-2):27-30. doi: 10.1016/j.jns.2010.11.011. Epub 2010 Dec 4.
- Results publication: PubMed 16904574European Heart Rhythm Association; Heart Rhythm Society; Fuster V, Ryden 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, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. doi: 10.1016/j.jacc.2006.07.009. No abstract available.
- Results publication: PubMed 23070632Akdemir B, Altekin RE, Kucuk 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 to electrical cardioversion: a study on diagnostic accuracy. Anadolu Kardiyol Derg. 2013 Feb;13(1):18-25. doi: 10.5152/akd.2013.003. Epub 2012 Oct 12.
- Results publication: PubMed 11985905Antonielli E, Pizzuti A, Palinkas A, Tanga M, Gruber N, Michelassi C, Varga A, Bonzano A, Gandolfo N, Halmai L, Bassignana A, Imran MB, Delnevo F, Csanady M, Picano E. Clinical value of left atrial appendage flow for prediction of long-term sinus rhythm maintenance in patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2002 May 1;39(9):1443-9. doi: 10.1016/s0735-1097(02)01800-4.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Galin, MD principal investigator
Danbury Hospital, Nuvance Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Danbury Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transthoracic Echocardiography and Transesophageal Echocardiography findings (time frame: 30 days post electrical cardioversion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655443, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.