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

This study is ongoing, but not recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Stroke Prevention
Left Atrial Appendage
 Device: WATCHMAN LAA system (Percutaneous left atrial appendage closure)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventional Study to Investigate the Effects of Percutaneous Closure of the Left Atrial Appendage on Atrial and Brain Natriuretic Peptide Secretion

Resource links provided by NLM:

Drug Information available for: Nesiritide
U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
atrial and brain natriuretic peptide
Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522911

Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Nicolas Majunke, M.D. HearCenter Leipzig
Principal Investigator: Sven Moebius-Winkler, M.D. HearCenter Leipzig
Principal Investigator: Gerhard Schuler, Professor HearCenter Leipzig
  More Information

No publications provided

Responsible Party: Nicolas Majunke, senior physician, University of Leipzig
ClinicalTrials.gov Identifier: NCT01522911     History of Changes
Other Study ID Numbers: LAA-1
Study First Received: December 20, 2011
Last Updated: January 30, 2012
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013