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Atrial FibrillationGERAFNCT05337202

the Dutch-GERAF Study

An observational study of Atrial Fibrillation and Frailty, run by Dijklander Ziekenhuis at 6 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Atrial Fibrillation, Frailty, Major Bleed
What is being tested?
HeartSDK
Type of treatment
Medical device
How many people
1,075 participants
Where
6 sitesNetherlands
Study dates
25 Jan 2021to 30 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Noordwest ziekenhuisgroep

    Alkmaar, 1815 JD

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Rijnstate

    Arnhem, Gelderland, 6815 AD

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Dijklander Ziekenhuis

    Hoorn, North Holland, 1624NP

Other trials in Netherlands

About this study

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

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.

Being tested
HeartSDK
Keywords
Atrial Fibrillation, Frailty, Major Bleed, Intra cranial Haemorrhage, Cognitive disorder, eHealth
Medical subject headings
Atrial Fibrillation, Frailty, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeartSDKDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Newly identified cases of atrial fibrillation

    PPG or ECG detected new cases of atrial fibrillation

    Measured: The first 6 months after recruitment for the study

Secondary outcomes (5)

  1. Major bleeding

    Major bleeding, including intra cranial haemorrhage

    Measured: From recruitment until 3 years after the recruitment of the last participant

  2. Stroke

    Stroke

    Measured: From recruitment until 3 years after the recruitment of the last participant

  3. Death

    Death

    Measured: From recruitment until 3 years after the recruitment of the last participant

  4. Cognitive disorder

    Development of dementia, categorized by aetiology, during follow up

    Measured: From recruitment until 3 years after the recruitment of the last participant

  5. New Atrial Fibrillation, developed after the screening period

    New Atrial Fibrillation, developed after the screening period

    Measured: From recruitment until 3 years after the recruitment of the last participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start25 Jan 2021
  3. Primary completion26 Oct 2022
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,075 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337202
Sponsor's protocol ID
WB 694
Acronym
GERAF
Status last verified
Feb 2024
First submitted
13 Apr 2022
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Upon reasonable request, anonymized data could be shared after approval of all principal investigators

Publications

  • 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.

    PubMed 35265881

  • 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.

    PubMed 32860505

  • 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.

    PubMed 32280331

  • 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.

    PubMed 18826625

  • 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.

    PubMed 17634318

  • 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.

    PubMed 29890749

  • 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.

    PubMed 41808073

  • 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.

    PubMed 38619715

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Frailty, run by Dijklander Ziekenhuis at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Newly identified cases of atrial fibrillation (time frame: The first 6 months after recruitment for the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05337202, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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