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

NCT01522911 | Unknown

• 1 other identifier: LAA-1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Stroke Prevention; Left Atrial Appendage

Outcome Measures

Primary Outcomes (1)

• 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).

  participants will be followed for the duration of hospital stay, an expected average of 48 hours

Study Arms (1)

atrial and brain natriuretic peptide

OTHER

Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure

Device: WATCHMAN LAA system (Percutaneous left atrial appendage closure)

Interventions

WATCHMAN LAA system (Percutaneous left atrial appendage closure) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-valvular atrial fibrillation
• increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2)

You may not qualify if:

• Valvular-atrial fibrillation
• Low risk for thromboembolic complications CHADS-2-Score \< 2

Sponsors & Collaborators

• University of Leipzig: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Majunke, M.D.

  HearCenter Leipzig

  PRINCIPAL INVESTIGATOR

• Sven Moebius-Winkler, M.D.

  HearCenter Leipzig

  PRINCIPAL INVESTIGATOR

• Gerhard Schuler, Professor

  HearCenter Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: February 1, 2012
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 1, 2012

Record last verified: 2012-01