NCT00510900

Brief Summary

The proposed work seeks to further understand the effects of LAA occlusion on cardiac structure and function, and in homeostasis. Numerous studies have implicated the left atrial appendage (LAA) as the source of the vast majority of left atrial thrombi in the setting of AF3. The University of Pittsburgh Medical Center will be implanting a Left Atrial Appendage filter system (the WATCHMAN® Left Atrial Appendage Filter System, manufactured by Atritech, Inc.). We aim to follow these patients for six months post implant in order to assess their heart rhythm, function, and to do blood tests to evaluate for neurohormonal changes.

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 Aug 2005

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withdrawn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

August 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

August 1, 2007

Last Update Submit

January 4, 2016

Conditions

Atrial Fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Ability to give informed consent.
  • Patient will be enrolled in the WATCHMAN device trial at UPMC. 4 -Documented history of atrial fibrillation.

You may not qualify if:

  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center/Comprehensive Heart Ctr.

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

    PMID: 11343485BACKGROUND

  • Furberg CD, Psaty BM, Manolio TA, Gardin JM, Smith VE, Rautaharju PM. Prevalence of atrial fibrillation in elderly subjects (the Cardiovascular Health Study). Am J Cardiol. 1994 Aug 1;74(3):236-41. doi: 10.1016/0002-9149(94)90363-8.

    PMID: 8037127BACKGROUND

  • Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82(5):547-54. doi: 10.1136/hrt.82.5.547.

    PMID: 10525506BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David S Schwartzman, MD

    University of Pittsburgh/UPMC

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

August 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

US(1)