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CompletedNCT07580937PROCEED-AFUpdated May 12, 2026

Studying Heart Ablation After Left Atrial Closure in High-Bleeding-Risk Atrial Fibrillation Patients

An observational study in Atrial Fibrillation and Atrial Arrhythmia, sponsored by University of Chicago. Completed at 20 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University of Chicago · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
198
Ages
18 Years and older
Sex
All
01

Study 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. Assessment will include characterization of patient characteristics, procedural details, management of post-procedure anticoagulation, and clinical outcomes.

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Conditions studied

  • Atrial Fibrillation
  • Atrial Arrhythmia

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Keywords

  • left atrial appendage occlusion (LAAO)
  • atrial fibrillation (AF) ablation
  • left atrial ablation
  • pulmonary vein isolation (PVI)
  • post-ablation oral anticoagulation
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 198 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation.

Inclusion criteria

  • Individuals aged >18 years
  • Undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation

Exclusion criteria

Exclusion Criteria:

  • Missing essential baseline characteristics and/or missing collection of sufficient details regarding each complication
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
198 participants (actual)
Patient registry
No

Groups and cohorts

  • Individuals undergoing atrial ablation for routine care

    Individuals undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation for routine care

    Other: Data collection

Interventions

  • OtherData collection

    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

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What researchers measure

Primary outcomes

  1. Patient characteristics

    Data will be collected to characterize patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation

    Time frame: Month 0, baseline

  2. 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

    Time frame: Month 0, during procedure

  3. Post-procedure anticoagulation management

    Data will be collected to characterize post-procedure anticoagulation management for patients with left atrial appendage occlusion devices

    Time frame: Through 24 months

  4. 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

    Time frame: 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

    Time frame: Through 6 months

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Study locations

20 sites
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Loyola University
    Chicago, Illinois 60660, United States
  • Northwestern University
    Evanston, Illinois 60208, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • OLV Hospital
    Aalst, Belgium
  • Nanjing Medical University
    Nanjing, China
  • Clinique Pasteur
    Toulouse, France
  • Cardioangiologisches Centrum Bethanien Frankfurt
    Frankfurt, Germany
  • University of Lübeck
    Lübeck, Germany
  • Ospedali Riuniti Umberto I°-Lancisi-Salesi
    Ancona, Italy
  • Asian Heart and Vascular Center
    Singapore, Singapore
  • University Hospital Basel
    Basel, Switzerland
  • University Hospital of Bern
    Bern, Switzerland
  • University of Liverpool
    Liverpool, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07580937
Lead sponsor
University of Chicago
Collaborators
Rush University
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Mar 8, 2022
Primary completion
Dec 10, 2024
Completion
Mar 30, 2026
Last update
May 12, 2026

Study contacts

Henry Huang, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
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 May 2026. You cannot join it, but the record below documents what was studied.

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