Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage
Primary Purpose
Atrial Fibrillation, Stroke Prevention, Left Atrial Appendage
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WATCHMAN LAA system (Percutaneous left atrial appendage closure)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- non-valvular atrial fibrillation
- increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2)
Exclusion Criteria:
- Valvular-atrial fibrillation
- Low risk for thromboembolic complications CHADS-2-Score < 2
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
atrial and brain natriuretic peptide
Arm Description
Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure
Outcomes
Primary Outcome Measures
Change from Baseline Plasma ANP and BNP levels after transcatheter closure of the left atrial appendage.
Venous blood samples are taken before the procedure, immediately after implantation of the LAA closure device and on the first morning after the procedure. The blood is drawn into plastic tubes containing aprotinin and ethylenediaminetetraacetic acid disodium and is promptly centrifuged. The plasma obtained is stored at -20°C until assayed. The plasma BNP and ANP concentrations are then determined with a commercially available enzyme immunoassay kit (ELISA Kit for Brain Natriuretic Peptide, Uscn Life Science Inc., Missouri City, USA and ANP ELISA Kit, Hölzel Diagnostika, Köln, Germany).
Secondary Outcome Measures
Full Information
NCT ID
NCT01522911
First Posted
December 20, 2011
Last Updated
January 30, 2012
Sponsor
University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT01522911
Brief Title
Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage
Official Title
Interventional Study to Investigate the Effects of Percutaneous Closure of the Left Atrial Appendage on Atrial and Brain Natriuretic Peptide Secretion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To date there are no data suggesting substantial effects of hormonal interaction after percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and consecutive release of the hormones may be reduced. Here, we present our experience of ANP and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke Prevention, Left Atrial Appendage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
atrial and brain natriuretic peptide
Arm Type
Other
Arm Description
Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure
Intervention Type
Device
Intervention Name(s)
WATCHMAN LAA system (Percutaneous left atrial appendage closure)
Intervention Description
The WATCHMAN LAA system (Altritech Inc., Plymouth, MN),Percutaneous occlusion systems have been developed as an alternative to anticoagulation for stroke prevention. Briefly, transseptal puncture is performed to gain access to the left atrial appendage (LAA). Thereafter LAA angiography is performed. After an optimal device size is chosen based on LAA measurements by fluoro and echocardiography the occluder is implanted into the orifice of the left atrial appendage under fluoroscopy and TEE-guidance. The size of the device is chosen to be 10% to 20% larger than diameter of the LAA ostium to have stable positioning of the device. Every procedure is performed under local anaesthesia. Heparin is given during implantation procedure to achieve an activated clotting time of at least 250.
Primary Outcome Measure Information:
Title
Change from Baseline Plasma ANP and BNP levels after transcatheter closure of the left atrial appendage.
Description
Venous blood samples are taken before the procedure, immediately after implantation of the LAA closure device and on the first morning after the procedure. The blood is drawn into plastic tubes containing aprotinin and ethylenediaminetetraacetic acid disodium and is promptly centrifuged. The plasma obtained is stored at -20°C until assayed. The plasma BNP and ANP concentrations are then determined with a commercially available enzyme immunoassay kit (ELISA Kit for Brain Natriuretic Peptide, Uscn Life Science Inc., Missouri City, USA and ANP ELISA Kit, Hölzel Diagnostika, Köln, Germany).
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-valvular atrial fibrillation
increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2)
Exclusion Criteria:
Valvular-atrial fibrillation
Low risk for thromboembolic complications CHADS-2-Score < 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Majunke, M.D.
Organizational Affiliation
HearCenter Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven Moebius-Winkler, M.D.
Organizational Affiliation
HearCenter Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, Professor
Organizational Affiliation
HearCenter Leipzig
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage
We'll reach out to this number within 24 hrs