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Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy

NCT04676880 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2024-06-21

No results posted yet for this study

Summary

Up to 5% of Atrial Fibrillation (AF) patients may have or develop contraindications to use oral anticoagulation (OAC). Randomized controlled trial (RCT) data suggest that Left Atrial Appendage Occlusion (LAAO) may provide a non-inferior alternative for cardioembolic stroke protection in patients tolerant to OAC. However, RCT data for LAAO is lacking in patients with contra-indications to OAC using antiplatelet (APT) or no therapy as usual care. The hypothesis underlying this trial is to demonstrate that LAAO is superior to usual care for the prevention of stroke.

Conditions

Interventions

DEVICE

Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)

Currently, there are two devices available on the Dutch market, Watchman and Amulet. After randomization to the intervention arm, additional randomization for type of device will follow. If the amount of procedures is too small to implant two devices, the centre will implant a device of choice.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • R&D Cardiologie

    lead OTHER

Principal Investigators

  • Lucas VA Boersma, Prof. Dr. · St Antonius Ziekenhuis Nieuwegein

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2026-05-01
Completion
2026-11-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676880 on ClinicalTrials.gov