Atrial FibrillationPROCEED-AFNCT07580937
Studying Heart Ablation After Left Atrial Closure in High-Bleeding-Risk Atrial Fibrillation Patients
An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by University of Chicago at 20 sites in 9 countries.
Trial summary
The purpose of this multicenter study is to collect information from routine clinical practices for patients with left atrial appendage occlusion (LAAO) devices presenting for pulmonary vein isolation (PVI) or left atrial ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Arrhythmia
- What is being tested?
- Data collection
- Type of treatment
- Pill or oral medicine
- How many people
- 198 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 8 Mar 2022to 30 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation.
Who may be able to join
- Individuals aged >18 years
- Undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation
Who cannot join
- Missing essential baseline characteristics and/or missing collection of sufficient details regarding each complication
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Loyola University
Chicago, Illinois, 60660
Northwestern University
Evanston, Illinois, 60208
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Germany2 sites
Cardioangiologisches Centrum Bethanien Frankfurt
Frankfurt
University of Lübeck
Lübeck
Switzerland2 sites
University Hospital Basel
Basel
University Hospital of Bern
Bern
About this study
Official title: Safety and Efficacy of Left Atrial Ablation After Percutaneous Left Atrial Appendage Occlusion in High-Bleeding-Risk Patients With Atrial Fibrillation: PROCEED-AF Ablation Registry
The purpose of this multicenter study is to collect information from routine clinical practices for patients with left atrial appendage occlusion (LAAO) devices presenting for pulmonary vein isolation (PVI) or left atrial ablation. Assessment will include characterization of patient characteristics, procedural details, management of post-procedure anticoagulation, and clinical outcomes.
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia
- Being tested
- Data collection
- Keywords
- left atrial appendage occlusion (LAAO), atrial fibrillation (AF) ablation, left atrial ablation, pulmonary vein isolation (PVI), post-ablation oral anticoagulation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection on patient characteristics and comorbidities, baseline echocardiographic data, home medications including oral anticoagulation regimen, ablation data, left atrial appendage occlusion device data, and complication-related details from routine procedures and encounters
| Study group | Role | What they receive |
|---|---|---|
| Individuals undergoing atrial ablation for routine care | Individuals undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation for routine care Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics
Data will be collected to characterize patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
Measured: Month 0, baseline
Procedural characteristics
Data will be collected to characterize pulmonary vein isolation or left atrial ablation procedural details for patients with left atrial appendage occlusion devices
Measured: Month 0, during procedure
Post-procedure anticoagulation management
Data will be collected to characterize post-procedure anticoagulation management for patients with left atrial appendage occlusion devices
Measured: Through 24 months
Clinical outcomes
Data will be collected to characterize clinical outcomes for patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
Measured: Through 24 months
Secondary outcomes (1)
Procedure-related complications
Data will be collected to characterize procedure-related complications for patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start8 Mar 2022
- Primary completion10 Dec 2024
- Study completion30 Mar 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 of ChicagoThe 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
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University
- Responsible party
- Sponsor
- Investigators
- Henry Huang, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580937
- Sponsor's protocol ID
- IRB26-0296
- Acronym
- PROCEED-AF
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Left Atrial Ablation After Percutaneous Left Atrial Appendage Occlusion in High-Bleeding-Risk Patients With Atrial Fibrillation: PROCEED-AF Ablation Registry
- ClinicalTrials.gov ID
- NCT07580937
- Acronym / sponsor ID
- PROCEED-AF / IRB26-0296
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia
- Keywords
- left atrial appendage occlusion (LAAO), atrial fibrillation (AF) ablation, left atrial ablation, pulmonary vein isolation (PVI), post-ablation oral anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Rush University
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 May 2026 (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.
The purpose of this multicenter study is to collect information from routine clinical practices for patients with left atrial appendage occlusion (LAAO) devices presenting for pulmonary vein isolation (PVI) or left atrial ablation. Assessment will include characterization of patient characteristics, procedural details, management of post-procedure anticoagulation, and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals undergoing atrial ablation for routine care | – | Other: Data collectionIndividuals undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation for routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation.
Key inclusion criteria (2 listed)
- Individuals aged >18 years
- Undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation
Key exclusion criteria (1 listed)
- Missing essential baseline characteristics and/or missing collection of sufficient details regarding each complication
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 |
|---|---|---|
| Data collectionData collection on patient characteristics and comorbidities, baseline echocardiographic data, home medications including oral anticoagulation regimen, ablation data, left atrial appendage occlusion device data, and complication-related details from routine procedures and encounters | Other | Individuals undergoing atrial ablation for routine care |
Primary outcome
Patient characteristics
Time frame: Month 0, baseline
Data will be collected to characterize patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
Procedural characteristics
Time frame: Month 0, during procedure
Data will be collected to characterize pulmonary vein isolation or left atrial ablation procedural details for patients with left atrial appendage occlusion devices
Post-procedure anticoagulation management
Time frame: Through 24 months
Data will be collected to characterize post-procedure anticoagulation management for patients with left atrial appendage occlusion devices
Clinical outcomes
Time frame: Through 24 months
Data will be collected to characterize clinical outcomes for patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
1 secondary outcome
Procedure-related complications
Time frame: Through 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 12 May 2026.
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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.
Henry Huang, MD principal investigator
University of Chicago
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by University of Chicago at 20 sites in 9 countries.
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 2 inclusion and 1 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Switzerland, Belgium, China and 4 more countries. 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?
Patient characteristics (time frame: Month 0, baseline). The study lists 4 primary outcomes in all. 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 12 May 2026.