Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510900
Status:
WITHDRAWN
Last Update Posted:
2016-01-05
First Post:
2007-08-01
Brief Title:
Effects of Left Atrial Appendage Occlusion
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effects of Left Atrial Appendage Occlusion
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
1 Blood tests to monitor biochemical markers of cardiac remodeling and indices of heart function We will assess atrial natriuretic factor brain natriuretic peptide norepinephrine matrix metalloproteinases 1 2 3 8 9 and 13 gelatinases 2 and 9 soluble tumor necrotic factor-II angiotensin aldosterone ADH rennin interleukin-6 TNF-α homocysteine C-reactive protein quantitative D-dimer fibrin fibrinogen and fibrin split products Biochemical markers of cardiac remodeling are being intensively studied globally with novel markers discovered and published frequently Serum will be banked for the duration of the study to allow for retrospective investigation of newly published markers
2 Echocardiogram to evaluate myocardial function and atrial work
3 24 hour holter monitor to evaluate the subjects heart rhythm for presence or absence of atrial fibrillation
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
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
1 Blood tests to monitor biochemical markers of cardiac remodeling and indices of heart function We will assess atrial natriuretic factor brain natriuretic peptide norepinephrine matrix metalloproteinases 1 2 3 8 9 and 13 gelatinases 2 and 9 soluble tumor necrotic factor-II angiotensin aldosterone ADH rennin interleukin-6 TNF-α homocysteine C-reactive protein quantitative D-dimer fibrin fibrinogen and fibrin split products Biochemical markers of cardiac remodeling are being intensively studied globally with novel markers discovered and published frequently Serum will be banked for the duration of the study to allow for retrospective investigation of newly published markers
2 Echocardiogram to evaluate myocardial function and atrial work
3 24 hour holter monitor to evaluate the subjects heart rhythm for presence or absence of atrial fibrillation
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None