Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Leipzig.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Nicolas Majunke, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01522911
First received: December 20, 2011
Last updated: January 30, 2012
Last verified: January 2012

December 20, 2011
January 30, 2012
May 2010
January 2012   (final data collection date for primary outcome measure)
Change from Baseline Plasma ANP and BNP levels after transcatheter closure of the left atrial appendage. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 48 hours ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01522911 on ClinicalTrials.gov Archive Site
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Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage
Interventional Study to Investigate the Effects of Percutaneous Closure of the Left Atrial Appendage on Atrial and Brain Natriuretic Peptide Secretion

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Stroke Prevention
  • Left Atrial Appendage
Device: WATCHMAN LAA system (Percutaneous left atrial appendage closure)
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.
atrial and brain natriuretic peptide
Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure
Intervention: Device: WATCHMAN LAA system (Percutaneous left atrial appendage closure)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01522911
LAA-1
No
Nicolas Majunke, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Nicolas Majunke, M.D. HearCenter Leipzig
Principal Investigator: Sven Moebius-Winkler, M.D. HearCenter Leipzig
Principal Investigator: Gerhard Schuler, Professor HearCenter Leipzig
University of Leipzig
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP