Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

New Onset Atrial Fibrillation Clinical Trial

Official title:

Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring and Cardiac Imaging in Patients at Low Risk for Cardiovascular Events Following Direct Current Cardioversion for New Onset Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038944
• Other study ID #: 18-19
• Status: Recruiting
• Start date: July 17, 2019
• Est. completion date: September 2023

Study information

• Verified date: July 2019
• Source: St. Francis Hospital, New York
• Contact: Joseph Levine, MD
• Phone: 516-742-5700
• Email: joseph.levine[@]chsli.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This pilot study aims to assess the feasibility and safety of using an ILR to identify the incidence of recurrent AF after an episode of newly diagnosed AF. The study further aims to assess the risk of AF recurrence in this low risk population based on left atrial and left atrial appendage anatomic and functional indices in addition to the standardized clinical CHA2DS2-Vasc score.

Description:

There is a significant incidence of recurrent AF following initial diagnosis of AF.

Inclusion of left atrial (LA) and left atrial appendage (LAA) abnormalities together with risk prediction of CVA using CHA2DS2-Vasc score will identify patients at low or high risk for adverse cardiovascular events in patients with manifest and silent AF.

Patients requiring cardioversion have higher risk of recurrent AF in follow up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2023
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Newly diagnosed AF

3. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule

Exclusion Criteria:

1. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint

2. Patient received an organ transplant, or is on a waiting list.

3. Patient is not able to follow instructions for remote monitoring 4 Prior history of AF

Related Conditions & MeSH terms

• Atrial Fibrillation
• New Onset Atrial Fibrillation

Locations

Country	Name	City	State
United States	St Francis Hospital	Roslyn	New York
United States	St. Francis Hospital	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Francis Hospital, New York

Country where clinical trial is conducted

United States, 

References & Publications (13)

Andersson T, Magnuson A, Bryngelsson IL, Frøbert O, Henriksson KM, Edvardsson N, Poçi D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14. — View Citation

Bai Y, Wang YL, Shantsila A, Lip GYH. The Global Burden of Atrial Fibrillation and Stroke: A Systematic Review of the Clinical Epidemiology of Atrial Fibrillation in Asia. Chest. 2017 Oct;152(4):810-820. doi: 10.1016/j.chest.2017.03.048. Epub 2017 Apr 17. Review. — View Citation

Calenda BW, Fuster V, Halperin JL, Granger CB. Stroke risk assessment in atrial fibrillation: risk factors and markers of atrial myopathy. Nat Rev Cardiol. 2016 Sep;13(9):549-59. doi: 10.1038/nrcardio.2016.106. Epub 2016 Jul 7. Review. — View Citation

European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. Erratum in: Eur Heart J. 2011 May;32(9):1172. — View Citation

Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001 Jun 13;285(22):2864-70. — View Citation

Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. — View Citation

Goldberger JJ, Arora R, Green D, Greenland P, Lee DC, Lloyd-Jones DM, Markl M, Ng J, Shah SJ. Evaluating the Atrial Myopathy Underlying Atrial Fibrillation: Identifying the Arrhythmogenic and Thrombogenic Substrate. Circulation. 2015 Jul 28;132(4):278-91. doi: 10.1161/CIRCULATIONAHA.115.016795. Review. — View Citation

Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. — View Citation

Hijazi Z, Lindahl B, Oldgren J, Andersson U, Lindbäck J, Granger CB, Alexander JH, Gersh BJ, Hanna M, Harjola VP, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Repeated Measurements of Cardiac Biomarkers in Atrial Fibrillation and Validation of the ABC Stroke Score Over Time. J Am Heart Assoc. 2017 Jun 23;6(6). pii: e004851. doi: 10.1161/JAHA.116.004851. — View Citation

Hijazi Z, Lindbäck J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25. — View Citation

Hijazi Z, Oldgren J, Lindbäck J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Yusuf S, Granger CB, Siegbahn A, Wallentin L; ARISTOTLE and RE-LY Investigators. A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score. Eur Heart J. 2018 Feb 7;39(6):477-485. doi: 10.1093/eurheartj/ehx584. — View Citation

Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017 Apr 28;120(9):1501-1517. doi: 10.1161/CIRCRESAHA.117.309732. Review. — View Citation

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to AF recurrence	Time to AF recurrence based on clinical or ILR monitoring	3 years
Secondary	All cause death	Composite endpoint of all-cause death	30 days; 6 months; 1 year; 2 years; 3 years
Secondary	AF related re hospitalizations	any hospitalization related to AFib	3 years
Secondary	Occurrence of CVA	Stroke mRs>1 or TIA	3 years
Secondary	Major and minor bleeding	events of major and minor bleeding	3 years