Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation

NCT ID: NCT04922281

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2026-12-31

Brief Summary

To prospectively investigate the efficacy of an insertable cardiac monitor-guided atrial fibrillation (AF) management in reducing subsequent AF burden in patients with persistent or paroxysmal AF undergoing atrial catheter ablation (CA).

Detailed Description

In this study, 120 subjects from the University of Rochester enrolling site will be randomized (1:1) to conventional AF management vs. Abbott ICM- guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days) or persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF ablation and Abbott ICM implantation. The Abbott ICM incorporates a mobile app (myMerlin) that allows early detection of AF recurrence through patient-triggered remote transmissions and correlation with symptoms based on subclinical AF (SCAF) and patient-triggered remote transmissions. Future FDA-approved Abbott ICM devices using the same functionality may also be utilized in this study. This is a Phase 4 study, and we are comparing two management strategies that are currently employed in clinical practice.

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Pathologic Processes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ICM/CIED/non-invasive LT-ECG patch arrhythmia detection guided Management

Implantable device (ICM/CIED) that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics). The CAM™ is patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Group Type: ACTIVE_COMPARATOR

Insertable Cardiac Monitor or external non-invasive LT-ECG patch

Intervention Type: DEVICE

Implantable device that provides accurate daily transmission. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics) the CAM™ patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Conventional Management

Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).

Group Type: PLACEBO_COMPARATOR

Insertable Cardiac Monitor or external non-invasive LT-ECG patch

Intervention Type: DEVICE

Implantable device that provides accurate daily transmission. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics) the CAM™ patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Interventions

Insertable Cardiac Monitor or external non-invasive LT-ECG patch

Implantable device that provides accurate daily transmission. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics) the CAM™ patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Intervention Type: DEVICE

Other Intervention Names

Confirm Rx™; Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics).The CAM™ patch.

Eligibility Criteria

Inclusion Criteria

• History of paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days), according to current guideline indications for paroxysmal AF CA (Class I/II); or patients with history of persistent atrial fibrillation (per 2019 HRS guidelines definition: sustained AF episode lasting more than 7 days, but less than 3 years), according to current guideline indications for persistent AF CA (Class I/IIIa) any time in the past.
• 18 years of age or older at time of consent
• CA to be performed for AF as standard of care within 2 calendar months after consent and prior to randomization date
• One of the following:

• Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 2 calendar months after consent and prior to randomization date
• Patients with an existing CIED (ICD/CRTD/PPM/ICM) are allowed if there is an atrial lead to track AF.
• Patient without an existing CIED preferring to use a noninvasive LT-ECG monitor.

Exclusion Criteria

• Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA)
• Inability to tolerate any AAD therapy
• Permanent atrial fibrillation lasting more than 3 years prior to date of consent
• NYHA class IV congestive heart failure
• Life expectancy <1 year after consent date for any medical condition
• Pregnancy or nursing
• Unwillingness to comply with all post-procedural follow-up requirements and to sign informed consent
• Participation in other interventional research studies (observational registries are allowed).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ilan Goldenberg

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilan Goldenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

Writing Group Members; January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS focused update of the 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 Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2019 Aug;16(8):e66-e93. doi: 10.1016/j.hrthm.2019.01.024. Epub 2019 Jan 28. No abstract available.

Reference Type: BACKGROUND

PMID: 30703530 (View on PubMed)

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: executive summary: 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):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.

Reference Type: BACKGROUND

PMID: 24682348 (View on PubMed)

Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

Reference Type: BACKGROUND

PMID: 27567408 (View on PubMed)

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. Epub 2011 May 3.

Reference Type: BACKGROUND

PMID: 21540439 (View on PubMed)

Terasawa T, Balk EM, Chung M, Garlitski AC, Alsheikh-Ali AA, Lau J, Ip S. Systematic review: comparative effectiveness of radiofrequency catheter ablation for atrial fibrillation. Ann Intern Med. 2009 Aug 4;151(3):191-202. doi: 10.7326/0003-4819-151-3-200908040-00131. Epub 2009 Jul 6.

Reference Type: BACKGROUND

PMID: 19581635 (View on PubMed)

Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

Reference Type: BACKGROUND

PMID: 9725923 (View on PubMed)

Arbelo E, Brugada J, Hindricks G, Maggioni AP, Tavazzi L, Vardas P, Laroche C, Anselme F, Inama G, Jais P, Kalarus Z, Kautzner J, Lewalter T, Mairesse GH, Perez-Villacastin J, Riahi S, Taborsky M, Theodorakis G, Trines SA; Atrial Fibrillation Ablation Pilot Study Investigators. The atrial fibrillation ablation pilot study: a European Survey on Methodology and results of catheter ablation for atrial fibrillation conducted by the European Heart Rhythm Association. Eur Heart J. 2014 Jun 7;35(22):1466-78. doi: 10.1093/eurheartj/ehu001. Epub 2014 Jan 31.

Reference Type: BACKGROUND

PMID: 24487524 (View on PubMed)

Kuck KH, Hoffmann BA, Ernst S, Wegscheider K, Treszl A, Metzner A, Eckardt L, Lewalter T, Breithardt G, Willems S; Gap-AF-AFNET 1 Investigators*. Impact of Complete Versus Incomplete Circumferential Lines Around the Pulmonary Veins During Catheter Ablation of Paroxysmal Atrial Fibrillation: Results From the Gap-Atrial Fibrillation-German Atrial Fibrillation Competence Network 1 Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003337. doi: 10.1161/CIRCEP.115.003337.

Reference Type: BACKGROUND

PMID: 26763226 (View on PubMed)

Hosseini SM, Rozen G, Saleh A, Vaid J, Biton Y, Moazzami K, Heist EK, Mansour MC, Kaadan MI, Vangel M, Ruskin JN. Catheter Ablation for Cardiac Arrhythmias: Utilization and In-Hospital Complications, 2000 to 2013. JACC Clin Electrophysiol. 2017 Nov;3(11):1240-1248. doi: 10.1016/j.jacep.2017.05.005. Epub 2017 Aug 2.

Reference Type: BACKGROUND

PMID: 29759619 (View on PubMed)

Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2.

Reference Type: BACKGROUND

PMID: 19808490 (View on PubMed)

Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

Reference Type: BACKGROUND

PMID: 27042964 (View on PubMed)

Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

Reference Type: BACKGROUND

PMID: 25946280 (View on PubMed)

Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.

Reference Type: BACKGROUND

PMID: 30874766 (View on PubMed)

Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

Reference Type: BACKGROUND

PMID: 28506916 (View on PubMed)

Darkner S, Chen X, Hansen J, Pehrson S, Johannessen A, Nielsen JB, Svendsen JH. Recurrence of arrhythmia following short-term oral AMIOdarone after CATheter ablation for atrial fibrillation: a double-blind, randomized, placebo-controlled study (AMIO-CAT trial). Eur Heart J. 2014 Dec 14;35(47):3356-64. doi: 10.1093/eurheartj/ehu354. Epub 2014 Sep 2.

Reference Type: BACKGROUND

PMID: 25182250 (View on PubMed)

Verma A, Kilicaslan F, Pisano E, Marrouche NF, Fanelli R, Brachmann J, Geunther J, Potenza D, Martin DO, Cummings J, Burkhardt JD, Saliba W, Schweikert RA, Natale A. Response of atrial fibrillation to pulmonary vein antrum isolation is directly related to resumption and delay of pulmonary vein conduction. Circulation. 2005 Aug 2;112(5):627-35. doi: 10.1161/CIRCULATIONAHA.104.533190.

Reference Type: BACKGROUND

PMID: 16061753 (View on PubMed)

Callans DJ, Gerstenfeld EP, Dixit S, Zado E, Vanderhoff M, Ren JF, Marchlinski FE. Efficacy of repeat pulmonary vein isolation procedures in patients with recurrent atrial fibrillation. J Cardiovasc Electrophysiol. 2004 Sep;15(9):1050-5. doi: 10.1046/j.1540-8167.2004.04052.x.

Reference Type: BACKGROUND

PMID: 15363079 (View on PubMed)

Nanthakumar K, Plumb VJ, Epstein AE, Veenhuyzen GD, Link D, Kay GN. Resumption of electrical conduction in previously isolated pulmonary veins: rationale for a different strategy? Circulation. 2004 Mar 16;109(10):1226-9. doi: 10.1161/01.CIR.0000121423.78120.49. Epub 2004 Mar 1.

Reference Type: BACKGROUND

PMID: 14993124 (View on PubMed)

Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.

Reference Type: BACKGROUND

PMID: 19995881 (View on PubMed)

Lellouche N, Jais P, Nault I, Wright M, Bevilacqua M, Knecht S, Matsuo S, Lim KT, Sacher F, Deplagne A, Bordachar P, Hocini M, Haissaguerre M. Early recurrences after atrial fibrillation ablation: prognostic value and effect of early reablation. J Cardiovasc Electrophysiol. 2008 Jun;19(6):599-605. doi: 10.1111/j.1540-8167.2008.01188.x. Epub 2008 May 5.

Reference Type: BACKGROUND

PMID: 18462321 (View on PubMed)

Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Turov A, Shirokova N, Karaskov A. Use of an implantable monitor to detect arrhythmia recurrences and select patients for early repeat catheter ablation for atrial fibrillation: a pilot study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):823-31. doi: 10.1161/CIRCEP.111.964809. Epub 2011 Sep 19.

Reference Type: BACKGROUND

PMID: 21930653 (View on PubMed)

Alipour P, Azizi Z, Pirbaglou M, Ritvo P, Pantano A, Verma A, Khaykin Y. Defining Blanking Period Post-Pulmonary Vein Antrum Isolation. JACC Clin Electrophysiol. 2017 Jun;3(6):568-576. doi: 10.1016/j.jacep.2017.01.006. Epub 2017 Mar 29.

Reference Type: BACKGROUND

PMID: 29759429 (View on PubMed)

Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7.

Reference Type: BACKGROUND

PMID: 23748210 (View on PubMed)

Eitel C, Husser D, Hindricks G, Fruhauf M, Hilbert S, Arya A, Gaspar T, Wetzel U, Bollmann A, Piorkowski C. Performance of an implantable automatic atrial fibrillation detection device: impact of software adjustments and relevance of manual episode analysis. Europace. 2011 Apr;13(4):480-5. doi: 10.1093/europace/euq511. Epub 2011 Feb 16.

Reference Type: BACKGROUND

PMID: 21325346 (View on PubMed)

Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11.

Reference Type: BACKGROUND

PMID: 16009793 (View on PubMed)

Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006 Dec;3(12):1445-52. doi: 10.1016/j.hrthm.2006.07.030. Epub 2006 Aug 3.

Reference Type: BACKGROUND

PMID: 17161787 (View on PubMed)

Lewalter T, Boriani G. Relevance of Monitoring Atrial Fibrillation in Clinical Practice. Arrhythm Electrophysiol Rev. 2012 Sep;1(1):54-58. doi: 10.15420/aer.2012.1.54.

Reference Type: BACKGROUND

PMID: 26835031 (View on PubMed)

Zuern CS, Kilias A, Berlitz P, Seizer P, Gramlich M, Muller K, Duckheim M, Gawaz M, Schreieck J. Anticoagulation after catheter ablation of atrial fibrillation guided by implantable cardiac monitors. Pacing Clin Electrophysiol. 2015 Jun;38(6):688-93. doi: 10.1111/pace.12625. Epub 2015 Apr 13.

Reference Type: BACKGROUND

PMID: 25753968 (View on PubMed)

Verma A, Champagne J, Sapp J, Essebag V, Novak P, Skanes A, Morillo CA, Khaykin Y, Birnie D. Discerning the incidence of symptomatic and asymptomatic episodes of atrial fibrillation before and after catheter ablation (DISCERN AF): a prospective, multicenter study. JAMA Intern Med. 2013 Jan 28;173(2):149-56. doi: 10.1001/jamainternmed.2013.1561.

Reference Type: BACKGROUND

PMID: 23266597 (View on PubMed)

Pedrote A, Arana-Rueda E, Garcia-Riesco L, Sanchez-Brotons J, Duran-Guerrero M, Gomez-Pulido F, Arce-Leon A, Frutos-Lopez M. Paroxysmal atrial fibrillation burden before and after pulmonary veins isolation: an observational study through a subcutaneous leadless cardiac monitor. J Cardiovasc Electrophysiol. 2013 Oct;24(10):1075-82. doi: 10.1111/jce.12190. Epub 2013 Jun 21.

Reference Type: BACKGROUND

PMID: 23790041 (View on PubMed)

Tondo C, Tritto M, Landolina M, DE Girolamo P, Bencardino G, Moltrasio M, Dello Russo A, Della Bella P, Bertaglia E, Proclemer A, DE Sanctis V, Mantica M. Rhythm-symptom correlation in patients on continuous monitoring after catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Feb;25(2):154-60. doi: 10.1111/jce.12292. Epub 2013 Oct 21.

Reference Type: BACKGROUND

PMID: 24102697 (View on PubMed)

Wechselberger S, Kronborg M, Huo Y, Piorkowski J, Neudeck S, Passler E, El-Armouche A, Richter U, Mayer J, Ulbrich S, Pu L, Kirstein B, Gaspar T, Piorkowski C. Continuous monitoring after atrial fibrillation ablation: the LINQ AF study. Europace. 2018 Nov 1;20(FI_3):f312-f320. doi: 10.1093/europace/euy038.

Reference Type: BACKGROUND

PMID: 29688326 (View on PubMed)

Hohnloser SH, Capucci A, Fain E, Gold MR, van Gelder IC, Healey J, Israel CW, Lau CP, Morillo C, Connolly SJ; ASSERT Investigators and Committees. ASymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial (ASSERT). Am Heart J. 2006 Sep;152(3):442-7. doi: 10.1016/j.ahj.2006.02.016.

Reference Type: BACKGROUND

PMID: 16923410 (View on PubMed)

Chen LY, Chung MK, Allen LA, Ezekowitz M, Furie KL, McCabe P, Noseworthy PA, Perez MV, Turakhia MP; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Stroke Council. Atrial Fibrillation Burden: Moving Beyond Atrial Fibrillation as a Binary Entity: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e623-e644. doi: 10.1161/CIR.0000000000000568. Epub 2018 Apr 16.

Reference Type: BACKGROUND

PMID: 29661944 (View on PubMed)

Gonzalez M, Keating RJ, Markowitz SM, Liu CF, Thomas G, Ip JE, Lerman BB, Cheung JW. Newly detected atrial high rate episodes predict long-term mortality outcomes in patients with permanent pacemakers. Heart Rhythm. 2014 Dec;11(12):2214-21. doi: 10.1016/j.hrthm.2014.08.019. Epub 2014 Aug 15.

Reference Type: BACKGROUND

PMID: 25131667 (View on PubMed)

Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

Reference Type: BACKGROUND

PMID: 31722151 (View on PubMed)

Pontoppidan J, Nielsen JC, Poulsen SH, Hansen PS. Symptomatic and asymptomatic atrial fibrillation after pulmonary vein ablation and the impact on quality of life. Pacing Clin Electrophysiol. 2009 Jun;32(6):717-26. doi: 10.1111/j.1540-8159.2009.02357.x.

Reference Type: BACKGROUND

PMID: 19545333 (View on PubMed)

Skalski J, Allison TG, Miller TD. The safety of cardiopulmonary exercise testing in a population with high-risk cardiovascular diseases. Circulation. 2012 Nov 20;126(21):2465-72. doi: 10.1161/CIRCULATIONAHA.112.110460. Epub 2012 Oct 22.

Reference Type: BACKGROUND

PMID: 23091065 (View on PubMed)

Kim YG, Shim J, Choi JI, Kim YH. Radiofrequency Catheter Ablation Improves the Quality of Life Measured with a Short Form-36 Questionnaire in Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis. PLoS One. 2016 Sep 28;11(9):e0163755. doi: 10.1371/journal.pone.0163755. eCollection 2016.

Reference Type: BACKGROUND

PMID: 27681507 (View on PubMed)

Kotecha D, Ahmed A, Calvert M, Lencioni M, Terwee CB, Lane DA. Patient-Reported Outcomes for Quality of Life Assessment in Atrial Fibrillation: A Systematic Review of Measurement Properties. PLoS One. 2016 Nov 1;11(11):e0165790. doi: 10.1371/journal.pone.0165790. eCollection 2016.

Reference Type: BACKGROUND

PMID: 27802324 (View on PubMed)

Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.

Reference Type: BACKGROUND

PMID: 21160035 (View on PubMed)

Ladapo JA, David G, Gunnarsson CL, Hao SC, White SA, March JL, Reynolds MR. Healthcare utilization and expenditures in patients with atrial fibrillation treated with catheter ablation. J Cardiovasc Electrophysiol. 2012 Jan;23(1):1-8. doi: 10.1111/j.1540-8167.2011.02130.x. Epub 2011 Jul 21.

Reference Type: BACKGROUND

PMID: 21777324 (View on PubMed)

Hunter RJ, Berriman TJ, Diab I, Kamdar R, Richmond L, Baker V, Goromonzi F, Sawhney V, Duncan E, Page SP, Ullah W, Unsworth B, Mayet J, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):31-8. doi: 10.1161/CIRCEP.113.000806. Epub 2014 Jan 1.

Reference Type: BACKGROUND

PMID: 24382410 (View on PubMed)

Fleiss JL. Analysis of data from multiclinic trials. Control Clin Trials. 1986 Dec;7(4):267-75. doi: 10.1016/0197-2456(86)90034-6.

Reference Type: BACKGROUND

PMID: 3802849 (View on PubMed)

Hilgers RD, Manolov M, Heussen N, Rosenberger WF. Design and analysis of stratified clinical trials in the presence of bias. Stat Methods Med Res. 2020 Jun;29(6):1715-1727. doi: 10.1177/0962280219846146. Epub 2019 May 10.

Reference Type: BACKGROUND

PMID: 31074333 (View on PubMed)

Xi W, Pennell ML, Andridge RR, Paskett ED. Comparison of intent-to-treat analysis strategies for pre-post studies with loss to follow-up. Contemp Clin Trials Commun. 2018 May 9;11:20-29. doi: 10.1016/j.conctc.2018.05.008. eCollection 2018 Sep.

Reference Type: BACKGROUND

PMID: 30023456 (View on PubMed)

Huque MH, Carlin JB, Simpson JA, Lee KJ. A comparison of multiple imputation methods for missing data in longitudinal studies. BMC Med Res Methodol. 2018 Dec 12;18(1):168. doi: 10.1186/s12874-018-0615-6.

Reference Type: BACKGROUND

PMID: 30541455 (View on PubMed)

Beinart SC, Natale A, Verma A, Amin A, Kasner S, Diener HC, Pouliot E, Franco N, Mittal S. Real-World Use of Prophylactic Antibiotics in Insertable Cardiac Monitor Procedures. Pacing Clin Electrophysiol. 2016 Aug;39(8):837-42. doi: 10.1111/pace.12886. Epub 2016 Jun 7.

Reference Type: BACKGROUND

PMID: 27198480 (View on PubMed)

Schmidt M, Dorwarth U, Andresen D, Brachmann J, Kuck KH, Kuniss M, Lewalter T, Spitzer S, Willems S, Senges J, Junger C, Hoffmann E. Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry. J Cardiovasc Electrophysiol. 2014 Jan;25(1):1-7. doi: 10.1111/jce.12267. Epub 2013 Oct 17.

Reference Type: BACKGROUND

PMID: 24134539 (View on PubMed)

Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.

Reference Type: BACKGROUND

PMID: 20160169 (View on PubMed)

Gerstenfeld EP, Callans DJ, Dixit S, Zado E, Marchlinski FE. Incidence and location of focal atrial fibrillation triggers in patients undergoing repeat pulmonary vein isolation: implications for ablation strategies. J Cardiovasc Electrophysiol. 2003 Jul;14(7):685-90. doi: 10.1046/j.1540-8167.2003.03013.x.

Reference Type: BACKGROUND

PMID: 12930245 (View on PubMed)

Other Identifiers

R61HL153001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005723

Identifier Type: -

Identifier Source: org_study_id