Atrial FibrillationNCT02485288
PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
An observational study of Atrial Fibrillation, run by University of Pittsburgh at 4 sites in United States.
Trial summary
The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,500 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to Jul 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants for the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort will include patients identified through EHRs at the participating PaTH sites, using the eligibility criteria described below. We aim to recruit as many patients as possible from the target population, with one of the recruitment strategies producing a 50% enrollment rate.
Who may be able to join
- Age: 18 years or older at time of query
- Visits: 3 non-ED outpatient visits between 1/1/2011 and 12/31/2014
- AF : AF diagnosis documented between 1/1/2011 and 12/31/2014
- AF diagnosis can be coded EHR (on billing or problem lists) and/or derived from EKG reports
- AF diagnoses associated with surgery, certain thyroid conditions, or certain medications cannot count as the qualifying AF diagnosis for inclusion in this cohort.
Who cannot join
- Deceased
- Not proficient in English
- Already enrolled in the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort at another PaTH institution
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Jody McCullough
Hershey, Pennsylvania, 17033
Anuradha Paranjape
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.
Read the detailed description
The primary objective is to create the PaTH Network AF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on AF across the multiple institutions of the PaTH network. Creating the AF Clinician-Patient Partnership Cohort will involve:
- Recruiting patients with AF to participate in the PaTH Network AF Clinician-Patient Partnership Cohort
- Administering surveys to the AF Clinician-Patient Partnership Cohort approximately every 6 months to collect patient reported outcomes (PROs)
- Collecting individual patient health record data into the AF Clinician-Patient Partnership Cohort database
- Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.
- Identifying potential participants for future research studies.
The secondary objectives are to use the PaTH Network AF Clinician-Patient Partnership Cohort to answer patient-centered research questions including:
- What is the incidence of complications requiring re-hospitalization after an ablation procedure for AF?
- What are the predictors of major bleeding and stroke among patients that receive each anticoagulant class (vit K antagonist, direct factor X inhibitor, direct thrombin inhibitor)?
- Is the longitudinal change in applied cognition-executive function score in AF patients associated with the choice of rate versus rhythm control and anticoagulation strategy?
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
Create the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort which will allow the conduct of patient-centered observational studies on atrial fibrillation across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Penn State University, Temple University
- Responsible party
- Principal investigator, Kathleen McTigue, University of Pittsburgh
- Investigators
- Kathleen M McTigue, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485288
- Sponsor's protocol ID
- STUDY20110294
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2015
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Han HR, Jain SK, Naccarelli GV, Aggarwal V, Nazarian S. Association of sex, age and education level with patient reported outcomes in atrial fibrillation. BMC Cardiovasc Disord. 2019 Apr 5;19(1):85. doi: 10.1186/s12872-019-1059-6.
PubMed 30953478Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Jain S, Naccarelli G, Aggarwal V, Nazarian S. Association of sex and atrial fibrillation therapies with patient-reported outcomes. Heart. 2019 Nov;105(21):1642-1648. doi: 10.1136/heartjnl-2019-314881. Epub 2019 May 22.
PubMed 31118198
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
- ClinicalTrials.gov ID
- NCT02485288
- Acronym / sponsor ID
- STUDY20110294
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Penn State University, Temple University
- Study start
- Jun 2015
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- 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.
The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.
Detailed description
The primary objective is to create the PaTH Network AF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on AF across the multiple institutions of the PaTH network. Creating the AF Clinician-Patient Partnership Cohort will involve:
- Recruiting patients with AF to participate in the PaTH Network AF Clinician-Patient Partnership Cohort
- Administering surveys to the AF Clinician-Patient Partnership Cohort approximately every 6 months to collect patient reported outcomes (PROs)
- Collecting individual patient health record data into the AF Clinician-Patient Partnership Cohort database
- Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.
- Identifying potential participants for future research studies.
The secondary objectives are to use the PaTH Network AF Clinician-Patient Partnership Cohort to answer patient-centered research questions including:
- What is the incidence of complications requiring re-hospitalization after an ablation procedure for AF?
- What are the predictors of major bleeding and stroke among patients that receive each anticoagulant class (vit K antagonist, direct factor X inhibitor, direct thrombin inhibitor)?
- Is the longitudinal change in applied cognition-executive function score in AF patients associated with the choice of rate versus rhythm control and anticoagulation strategy?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants for the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort will include patients identified through EHRs at the participating PaTH sites, using the eligibility criteria described below. We aim to recruit as many patients as possible from the target population, with one of the recruitment strategies producing a 50% enrollment rate.
Key inclusion criteria (5 listed)
- Age: 18 years or older at time of query
- Visits: 3 non-ED outpatient visits between 1/1/2011 and 12/31/2014
- AF : AF diagnosis documented between 1/1/2011 and 12/31/2014
- AF diagnosis can be coded EHR (on billing or problem lists) and/or derived from EKG reports
- AF diagnoses associated with surgery, certain thyroid conditions, or certain medications cannot count as the qualifying AF diagnosis for inclusion in this cohort.
Key exclusion criteria (3 listed)
- Deceased
- Not proficient in English
- Already enrolled in the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort at another PaTH institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
Time frame: 18 months
Create the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort which will allow the conduct of patient-centered observational studies on atrial fibrillation across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 30953478Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Han HR, Jain SK, Naccarelli GV, Aggarwal V, Nazarian S. Association of sex, age and education level with patient reported outcomes in atrial fibrillation. BMC Cardiovasc Disord. 2019 Apr 5;19(1):85. doi: 10.1186/s12872-019-1059-6.
- Background: PubMed 31118198Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Jain S, Naccarelli G, Aggarwal V, Nazarian S. Association of sex and atrial fibrillation therapies with patient-reported outcomes. Heart. 2019 Nov;105(21):1642-1648. doi: 10.1136/heartjnl-2019-314881. Epub 2019 May 22.
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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.
Kathleen M McTigue, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Pittsburgh at 4 sites in United States.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort (time frame: 18 months). 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 NCT02485288, which also lists 2 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 7 Oct 2026.