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

NCT ID: NCT01522911

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

atrial and brain natriuretic peptide

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

Group Type: OTHER

WATCHMAN LAA system (Percutaneous left atrial appendage closure)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Majunke

senior physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas Majunke, M.D.

Role: PRINCIPAL_INVESTIGATOR

HearCenter Leipzig

Sven Moebius-Winkler, M.D.

Role: PRINCIPAL_INVESTIGATOR

HearCenter Leipzig

Gerhard Schuler, Professor

Role: PRINCIPAL_INVESTIGATOR

HearCenter Leipzig

Other Identifiers

LAA-1

Identifier Type: -

Identifier Source: org_study_id