Atrial FibrillationEHRA-PATHSNCT05773768
EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways
A study testing EHRA-PATHS software tool in people with Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- EHRA-PATHS software tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2024to 1 Jul 2026
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways
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.
- Conditions
- Atrial Fibrillation
- Being tested
- EHRA-PATHS software tool
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHRA-PATHS software toolDevice
Newly developed care pathways integrated into a care-management software tool
| Study group | Role | What they receive |
|---|---|---|
| New care program | Experimental | 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. Receives: Device: EHRA-PATHS software tool |
| Routine clinical care | No intervention | The health care provider follows current clinical practice with regards to history taking, physical examination etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
AF symptom burden
Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire
Measured: 6 months
Quality of life (QoL)
Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire
Measured: 6 months
Referrals to other disciplines
The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.
Measured: 6 months
Patient and health care provider satisfaction
Measured with a patient and health care provider (HCP) satisfaction questionnaire
Measured: 6 months
Healthcare resource use/costs
Measured with the iMedical Consumption Questionnaire (iMCQ)
Measured: 6 months
HRQoL/utility
Measured with the EQ-5D-5L questionnaire (iMCQ)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start28 Mar 2024
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773768
- Sponsor's protocol ID
- EHRA-PATHS
- Other IDs
- 2024-A01056-41
- Acronym
- EHRA-PATHS
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways
- ClinicalTrials.gov ID
- NCT05773768
- Acronym / sponsor ID
- EHRA-PATHS / EHRA-PATHS
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New care program | Experimental | Device: EHRA-PATHS software toolThe 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. |
| Routine clinical care | No intervention | –The health care provider follows current clinical practice with regards to history taking, physical examination etc. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHRA-PATHS software toolNewly developed care pathways integrated into a care-management software tool | Device | New care program |
Primary outcome
Identification and management of risk factors and comorbidities
Time frame: 6 months
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.
6 secondary outcomes
AF symptom burden
Time frame: 6 months
Quality of life (QoL)
Time frame: 6 months
Referrals to other disciplines
Time frame: 6 months
Patient and health care provider satisfaction
Time frame: 6 months
Healthcare resource use/costs
Time frame: 6 months
HRQoL/utility
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHRA-PATHS software tool in people with Atrial Fibrillation, run by University Medical Center Groningen at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification and management of risk factors and comorbidities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.