the Dutch-GERAF Study

Atrial Fibrillation Clinical Trial

— GERAF  

Official title:

The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05337202
• Other study ID #: WB 694
• Status: Active, not recruiting
• Start date: January 25, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Dijklander Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1075
• Est. completion date: June 30, 2026
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

All newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including Fall clinic, Memory clinic, Pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician).

Exclusion Criteria:

• The patient has a pacemaker or implantable cardioverter defibrillator.
• The patient is known with a severe dementia, MoCA = 15 points.
• The patient has a severe tremor, from whatever cause, and thus is unable to use the PPG based smartphone AF detection algorithm.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Frailty
• Major Bleed

Intervention

Device:
• HeartSDK
The photoplethysmography (PPG) application enables patients to perform a finger tip heartbeat measurement and automatic analysis

Locations

Country	Name	City	State
Netherlands	Noordwest ziekenhuisgroep	Alkmaar
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Rijnstate	Arnhem	Gelderland
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Dijklander Ziekenhuis	Hoorn	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Dijklander Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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 I — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newly identified cases of atrial fibrillation	PPG or ECG detected new cases of atrial fibrillation	The first 6 months after recruitment for the study
Secondary	Major bleeding	Major bleeding, including intra cranial haemorrhage	From recruitment until 3 years after the recruitment of the last participant
Secondary	Stroke	Stroke	From recruitment until 3 years after the recruitment of the last participant
Secondary	Death	Death	From recruitment until 3 years after the recruitment of the last participant
Secondary	Cognitive disorder	Development of dementia, categorized by aetiology, during follow up	From recruitment until 3 years after the recruitment of the last participant
Secondary	New Atrial Fibrillation, developed after the screening period	New Atrial Fibrillation, developed after the screening period	From recruitment until 3 years after the recruitment of the last participant