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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07580937

Acronym

PROCEED-AF

Enrollment

198

Registered

2026-05-12

Start date

2022-03-08

Completion date

2026-03-30

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Arrhythmia, Atrial Fibrillation

Keywords

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

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.

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient characteristics	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	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	Through 24 months	Data will be collected to characterize post-procedure anticoagulation management for patients with left atrial appendage occlusion devices
Clinical outcomes	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

Secondary

Measure	Time frame	Description
Procedure-related complications	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

Countries

Belgium, China, France, Germany, Italy, Singapore, Switzerland, United Kingdom, United States

Contacts

PRINCIPAL_INVESTIGATORHenry Huang, MD

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026