NCT02309268

Brief Summary

The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

August 1, 2014

Last Update Submit

June 11, 2015

Conditions

Atrial FibrillationLeft Atrial Appendage Closure

Keywords

left atrial appendage closure

Outcome Measures

Primary Outcomes (1)

  • Clinical Progress

    Patients who agree to participate in the registry will allow the Investigators to document their clinical progress and compare their progress to other participants in the study. Meanwhile, the patient will continue to receive routine care from their physician, just as they would if they did not participate in the study. Any information published as a result of this registry, will be kept anonymous. There is no known risk in participating in this study as it is only an observational study.

    At regular visits ( 3 months and annually)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being asked to take part in this study have a heart disorder known as atrial fibrillation (AF) and are poor candidates to take blood thinning drug known as warfarin (Coumadin), and have elected to undergo LARIAT procedure.

You may qualify if:

  • Patients with Atrial fibrillation
  • Are poor candidates to take warfarin
  • Have elected to undergo a LARIAT procedure

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • kenneth A Ellenbogen, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

December 5, 2014

Study Start

June 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

US(1)