Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Fibrillation Stroke Thromboembolism

Keywords

Atrial FibrillationStrokeLeft Atrial AppendageCardiac PlugAmuletThromboembolism

Outcome Measures

Primary Outcomes (3)

Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death
The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment
Implant through 24 months
Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism
The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
Implant through 24 months
Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair

Study Arms (1)

LAA Occluder PAS

Subjects who were treated with AMPLATZER LAA Occluders will be included.

Device: AMPLATZER™ LAA Occluder

Interventions

AMPLATZER™ LAA OccluderDevice

The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants.

Also known as: AMPLATZER™ Cardiac Plug™, AMPLATZER™ Amulet™

LAA Occluder PAS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The subject population will include participants that are \> 18 years old and diagnosed with NVAF.

You may qualify if:

years of age or older

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (22)

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province, 2000, Argentina

Hôpital Civil Marie Curie

Lodelinsart, Hainaut, 6042, Belgium

Royal Columbian

New Westminster, British Columbia, V3L 3W5, Canada

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2E8, Canada

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

MeSH Terms

Conditions

Atrial FibrillationThromboembolismStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title: Ryan Gage
Organization: Abbott

Study Officials

Ryan Palmer
Abbott
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

520 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

November 16, 2016

Study Start

December 8, 2016

Actual (reported)

AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

LAA Occluder PAS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

LAA Occluder PAS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Documents

Locations