Study on the Effectiveness of AF Analysis Software in AF Rhythm Monitoring

NCT05333380 | Unknown

• 1 other identifier: 2022-PPG-AF
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 2

Brief Summary

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. ECG is the most commonly used gold standard for clinical diagnosis of arrhythmias, but conventional ECG examinations are not adequate for long-term ECG follow-up measurements in patients with AF. In this study, the AF patients will wear an watch and ECG patch to continuously monitor ECG and PPG. The software uses an integrated diagnostic mechanism of "AF burden + AF segments" to efficiently analyze ECG and PPG data, which can quickly and accurately identify the occurrence of AF and analyze AF burden in real-time, facilitating physicians' diagnosis and treatment and efficacy assessment.

Conditions

Atrial Fibrillation; Atrial Fibrillation Paroxysmal

Outcome Measures

Primary Outcomes (1)

• The ECG and PPG data are automatically analyzed by the AF analysis software.

  The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.

  Two months after enrollment of the first subject

Secondary Outcomes (1)

• The AF burden calculated from PPG data is compared with that from ECG monitoring.

  Two months after enrollment of the first subject

Interventions

ECG/PPG monitoring DEVICE

The enrolled patients will wear an "ECG patch" and watch at the same time to collect ECG and PPG data respectively. The data collection time is from the day of hospitalization to before the ablation operation, and from 2 hours after the removal of ECG monitoring equipment to before leaving the hospital. The monitoring duration of each patient shall not be less than 18 hours.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation who were hospitalized in the Department of Cardiology, Beijing Anzhen Hospital, aged from 18 to 80,were included in the study.

You may qualify if:

• Be at least 18 years of age.
• Have clear ECG-recorded atrial fibrillation in the past and will undergo atrial fibrillation ablation in the current hospitalization.
• Patients who agree to wear both the watch and the ECG recorder.

You may not qualify if:

• Inability to wear the watch due to limited mobility or other problems.
• Severe skin diseases such as skin allergies or skin ulcers.
• Chronic insomnia not treated with medication.
• Patients with severe cardiovascular disease who may be resuscitated at any time.
• Previous history of Parkinson's, schizophrenia, epilepsy.
• Black people and those with excessively dark skin.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Heart Health Research Center: collaborator

Study Sites (2)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (9)

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  PMID: 25520374 BACKGROUND

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  PMID: 30049467 BACKGROUND

• Andrew NE, Thrift AG, Cadilhac DA. The prevalence, impact and economic implications of atrial fibrillation in stroke: what progress has been made? Neuroepidemiology. 2013;40(4):227-39. doi: 10.1159/000343667. Epub 2013 Jan 24.

  PMID: 23364221 BACKGROUND

• Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, Carolei A. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9. doi: 10.1161/01.STR.0000166053.83476.4a. Epub 2005 May 5.

  PMID: 15879330 BACKGROUND

• Witassek F, Springer A, Adam L, Aeschbacher S, Beer JH, Blum S, Bonati LH, Conen D, Kobza R, Kuhne M, Moschovitis G, Osswald S, Rodondi N, Sticherling C, Szucs T, Schwenkglenks M; Swiss-AF study investigators. Health-related quality of life in patients with atrial fibrillation: The role of symptoms, comorbidities, and the type of atrial fibrillation. PLoS One. 2019 Dec 23;14(12):e0226730. doi: 10.1371/journal.pone.0226730. eCollection 2019.

  PMID: 31869399 BACKGROUND

• McManus DD, Lee J, Maitas O, Esa N, Pidikiti R, Carlucci A, Harrington J, Mick E, Chon KH. A novel application for the detection of an irregular pulse using an iPhone 4S in patients with atrial fibrillation. Heart Rhythm. 2013 Mar;10(3):315-9. doi: 10.1016/j.hrthm.2012.12.001. Epub 2012 Dec 6.

  PMID: 23220686 BACKGROUND

• Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693.

  PMID: 28483832 BACKGROUND

• 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.

  PMID: 31722151 BACKGROUND

• Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch Performance for the Detection and Quantification of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e006834. doi: 10.1161/CIRCEP.118.006834.

  PMID: 31113234 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chang Sh Ma, Dr.

CONTACT

86-010-64412431; chshma@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Director

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 19, 2022
• Study Start: August 29, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

CN (2)