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OpenTrials
Completed

NCT Number: NCT07580937

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Arrhythmia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Hospital, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Rush University

Registry information

Official study 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

Acronym: PROCEED-AF

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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