Atrial FibrillationNCT00510900
Effects of Left Atrial Appendage Occlusion
An observational study of Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center/Comprehensive Heart Ctr.
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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:
- 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.
- Echocardiogram to evaluate myocardial function and atrial work.
- 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startAug 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S Schwartzman, MD, Principal investigator, University of Pittsburgh/UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510900
- Sponsor's protocol ID
- 0508103
- Status last verified
- Jan 2016
- First submitted
- 1 Aug 2007
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11343485Furberg 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.
PubMed 8037127Al-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.
PubMed 10525506
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT00510900
- Acronym / sponsor ID
- 0508103
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Echocardiogram to evaluate myocardial function and atrial work.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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.
Key exclusion criteria (1 listed)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 11343485Go 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.
- Background: PubMed 8037127Furberg 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.
- Background: PubMed 10525506Al-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.
Related trials for Atrial Fibrillation
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Schwartzman, MD principal investigator
University of Pittsburgh/UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510900, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.