Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

NCT04038944 | Unknown

• 1 other identifier: 18-19
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

New Onset Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Time to AF recurrence

  Time to AF recurrence based on clinical or ILR monitoring

  3 years

Secondary Outcomes (4)

• All cause death

  30 days; 6 months; 1 year; 2 years; 3 years

• AF related re hospitalizations

  3 years

• Occurrence of CVA

  3 years

• Major and minor bleeding

  3 years

Study Arms (1)

Subjects with new onset atrial fibrillation

Subjects with new onset atrial fibrillation who may or may not require electrical cardioversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The trial will include 250 subjects who have been identified with initial diagnosis of AF and for whom a rhythm control strategy has been chosen with the primary endpoint being time to AF recurrence, AF burden, and AF management at 1 and 3 years.

You may qualify if:

• Age ≥ 18 years
• Newly diagnosed AF
• Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule

You may not qualify if:

• Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint
• Patient received an organ transplant, or is on a waiting list.
• Patient is not able to follow instructions for remote monitoring 4 Prior history of AF

Sponsors & Collaborators

• St. Francis Hospital, New York: lead

Study Sites (2)

St Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

St. Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 28427968 BACKGROUND

• 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.

  PMID: 28450367 BACKGROUND

• 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. doi: 10.1161/01.str.22.8.983.

  PMID: 1866765 BACKGROUND

• Hijazi Z, Lindback 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.

  PMID: 26920728 BACKGROUND

• Hijazi Z, Oldgren J, Lindback 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.

  PMID: 29069359 BACKGROUND

• 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.

  PMID: 27383079 BACKGROUND

• 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.

  PMID: 26216085 BACKGROUND

• Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci 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.

  PMID: 23321349 BACKGROUND

• 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. doi: 10.7326/0003-4819-146-12-200706190-00007.

  PMID: 17577005 BACKGROUND

• 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. doi: 10.1001/jama.285.18.2370.

  PMID: 11343485 BACKGROUND

• 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. No abstract available.

  PMID: 20802247 BACKGROUND

• 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. doi: 10.1001/jama.285.22.2864.

  PMID: 11401607 BACKGROUND

• Hijazi Z, Lindahl B, Oldgren J, Andersson U, Lindback 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):e004851. doi: 10.1161/JAHA.116.004851.

  PMID: 28645934 BACKGROUND

Study Officials

• Joseph Levine, MD

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Levine, MD

CONTACT

516-742-5700; joseph.levine@chsli.org

Elizabeth S Haag, RN MPA

CONTACT

516 562-6790; elizabeth.haag@chsli.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: July 17, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2023
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)