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

January 30, 2012 updated by: Nicolas Majunke, University of Leipzig

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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