NCT05337202|Unknown
the Dutch-GERAF Study
GERAF
The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study
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GERAF
The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study
Sponsor study identifier
observational
1,075
1 country
6
Study Start
January 25, 2021
Actual (reported)Primary Completion
October 26, 2022
Actual (reported)Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. Often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. Furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients. This study applies opportunistic screening for atrial fibrillation as advised in the latest ESC Guideline on the diagnosis and management of atrial fibrillation. Furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2021
Actual (reported)April 13, 2022
Actual (reported)April 20, 2022
Actual (reported)October 26, 2022
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Newly identified cases of atrial fibrillation
PPG or ECG detected new cases of atrial fibrillation
The first 6 months after recruitment for the study
Major bleeding
From recruitment until 3 years after the recruitment of the last participant
Stroke
From recruitment until 3 years after the recruitment of the last participant
The photoplethysmography (PPG) application enables patients to perform a finger tip heartbeat measurement and automatic analysis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All newly referred patients of 65 years and older that visit a geriatric outpatient service. These will form a cohort of very elderly individuals, with multi morbidity, polypharmacy, cognitive disorders, high frailty and high risk for falling. They can also be seen as a group at high risk of cardiovascular complication and/or the development of cognitive disorders.
Rijnstate
Arnhem, Gelderland, 6815 AD, Netherlands
Dijklander Ziekenhuis
Hoorn, North Holland, 1624NP, Netherlands
Noordwest ziekenhuisgroep
Alkmaar, 1815 JD, Netherlands
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Zwart LAR, Germans T, Simsek S, Ruiter JH, Jansen RWMM. Atrial fibrillation, anticoagulation and major bleeding in geriatric patients at risk of falling. OBM Geriatrics 2019, Volume 3, Issue 3, doi:10.21926/obm.geriatr.1903071
Mol D, Riezebos RK, Marquering HA, Werner ME, Lobban TCA, de Jong JSSG, de Groot JR. Performance of an automated photoplethysmography-based artificial intelligence algorithm to detect atrial fibrillation. Cardiovasc Digit Health J. 2020 Oct 22;1(2):107-110. doi: 10.1016/j.cvdhj.2020.08.004. eCollection 2020 Sep-Oct. No abstract available.
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
Full blood
René Jansen, PhD
Northwest Hospital
1,075 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2022
First Posted
April 20, 2022
Study Start
January 25, 2021
Actual (reported)Death
From recruitment until 3 years after the recruitment of the last participant
Cognitive disorder
From recruitment until 3 years after the recruitment of the last participant
New Atrial Fibrillation, developed after the screening period
From recruitment until 3 years after the recruitment of the last participant
Contact the study team to confirm eligibility.
Zwart LA, Jansen RW, Ruiter JH, Germans T, Simsek S, Hemels ME. Opportunistic screening for atrial fibrillation with a single lead device in geriatric patients. J Geriatr Cardiol. 2020 Mar;17(3):149-154. doi: 10.11909/j.issn.1671-5411.2020.03.007.
Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.
Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.
Moraes JL, Rocha MX, Vasconcelos GG, Vasconcelos Filho JE, de Albuquerque VHC, Alexandria AR. Advances in Photopletysmography Signal Analysis for Biomedical Applications. Sensors (Basel). 2018 Jun 9;18(6):1894. doi: 10.3390/s18061894.
Spruit JR, Zwart L, Jansen R, Muller M, Groot JR, Hemels M. Polypharmacy and cardiovascular co-morbidity as key contributors to frailty in geriatric patients with AF - insights of the Dutch-GERAF cohort study. BMC Geriatr. 2026 Mar 10;26(1):539. doi: 10.1186/s12877-026-07189-0.
Dutch-GERAF investigators; Zwart LAR, Spruit JR, Hemels MEW, de Groot JR, Pisters R, Riezebos RK, Jansen RWMM. Design of the Dutch multicentre study on opportunistic screening of geriatric patients for atrial fibrillation using a smartphone PPG app: the Dutch-GERAF study. Neth Heart J. 2024 May;32(5):200-205. doi: 10.1007/s12471-024-01868-6. Epub 2024 Apr 15.
Primary Completion
October 26, 2022
Actual (reported)Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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