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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02309268
Other study ID # LARIAT
Secondary ID
Status Withdrawn
Phase N/A
First received August 1, 2014
Last updated June 11, 2015
Start date June 2012
Est. completion date October 2014

Study information

Verified date June 2015
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Description:

Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Patients with Atrial fibrillation

- Are poor candidates to take warfarin

- Have elected to undergo a LARIAT procedure

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Virginia Medical Center Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
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