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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.
Atrial fibrillation (AF), a heart rhythm disorder, is a major health problem. As many as 3 million US persons are afflicted; this number is expected to rise significantly in coming decades because AF incidence is directly correlated with age1. AF is significantly associated with cardiovascular morbidity and mortality.
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:
This study will be a non-blinded observational study with a control group. Subjects will be recruited from the patient pool of the Principal Investigator and Co-Investigators. All subjects in the intervention group will have had the WATCHMAN device implanted at UPMC. The control group in this trial will be comprised of age-matched controls from the control group in the WATCHMAN device trial, also from the patient pool of the Principal Investigator and Co-Investigators. Subjects will be approached by one of the Investigators.
The primary outcome of interest will be left atrial work, measured on a continuous scale. Analysis of covariance (ANCOVA) will be used to compare mean left atrial work scores at 12 months between the intervention and non-intervention patient groups adjusting for baseline values.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Schwartzman, MD | University of Pittsburgh/UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center/Comprehensive Heart Ctr. | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11343485 | Background | 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. | |
| 8037127 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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. |
| 10525506 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |