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

NCT07580937 | Completed

• 1 other identifier: IRB26-0296
• Study Type: observational
• Target: 198
• Locations: 9 countries
• Sites: 20

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• Patient characteristics

  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

  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

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

  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

  Through 24 months

Secondary Outcomes (1)

• Procedure-related complications

  Through 6 months

Study Arms (1)

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

Data collection OTHER

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

Individuals undergoing atrial ablation for routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead
• Rush University: collaborator

Study Sites (20)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University

Chicago, Illinois, 60660, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

OLV Hospital

Aalst, Belgium

Location

Nanjing Medical University

Nanjing, China

Location

Clinique Pasteur

Toulouse, France

Location

Cardioangiologisches Centrum Bethanien Frankfurt

Frankfurt, Germany

Location

University of Lübeck

Lübeck, Germany

Location

Ospedali Riuniti Umberto I°-Lancisi-Salesi

Ancona, Italy

Location

Asian Heart and Vascular Center

Singapore, Singapore

Location

University Hospital Basel

Basel, Switzerland

Location

University Hospital of Bern

Bern, Switzerland

Location

University of Liverpool

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Henry Huang, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: March 8, 2022
• Primary Completion: December 10, 2024
• Study Completion: March 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CN (1); GB (1); BE (1); CH (2); US (10); FR (1); DE (2); SG (1); IT (1)