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CompletedNCT05773768EHRA-PATHSUpdated Sep 28, 2026

EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways

An interventional study of EHRA-PATHS software tool in Atrial Fibrillation, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic

Updated Sep 28, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
703
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 703 is above the median of 144 across 2,381 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 610 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
  • ≥65 years of age
  • Willing and able to participate and to attend the scheduled follow-up visits.

Exclusion criteria

Exclusion Criteria:

  • Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
  • Life expectancy of less than 1 year
  • Participation in another clinical study (registry studies not included)
  • Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
703 participants (actual)

Study arms

  • Experimental
    New care program

    The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes.

    Device: EHRA-PATHS software tool

  • No intervention
    Routine clinical care

    The health care provider follows current clinical practice with regards to history taking, physical examination etc.

Interventions

  • DeviceEHRA-PATHS software tool

    Newly developed care pathways integrated into a care-management software tool

06

What researchers measure

Primary outcomes

  1. Identification and management of risk factors and comorbidities

    The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial.

    Time frame: 6 months

Secondary outcomes

  1. AF symptom burden

    Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire

    Time frame: 6 months

  2. Quality of life (QoL)

    Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire

    Time frame: 6 months

  3. Referrals to other disciplines

    The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.

    Time frame: 6 months

  4. Patient and health care provider satisfaction

    Measured with a patient and health care provider (HCP) satisfaction questionnaire

    Time frame: 6 months

  5. Healthcare resource use/costs

    Measured with the iMedical Consumption Questionnaire (iMCQ)

    Time frame: 6 months

  6. HRQoL/utility

    Measured with the EQ-5D-5L questionnaire (iMCQ)

    Time frame: 6 months

07

Study locations

1 site
  • University Medical Center Groningen
    Groningen, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 28, 2026
Primary completion
Jan 1, 2026→Jul 1, 2026 (actual)
Sep 28, 2026
Study completion
Jan 1, 2026→Jul 1, 2026 (actual)
Sep 28, 2026
Enrollment
1300 (estimated)→703 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Recruiting→Completed
    Primary completion Jan 1, 2026→Jul 1, 2026 (now actual)
    Study completion Jan 1, 2026→Jul 1, 2026 (now actual)
    Enrollment 1300 (estimated)→703 (actual)
    + 5 other changes: identifiers, verification date, site details, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05773768
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
Mar 17, 2023
Start date
Mar 28, 2024
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026
Last update
Sep 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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