Studying Heart Ablation After Left Atrial Closure in High-Bleeding-Risk Atrial Fibrillation Patients (PROCEED-AF)

May 5, 2026 updated by: University of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 0, baseline
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
Month 0, during procedure
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
Through 24 months
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
Through 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related complications
Time Frame: Through 6 months
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
Through 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Rush University

Investigators

  • Principal Investigator: Henry Huang, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB26-0296

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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