Impact of Left Atrial Appendage Closure on Physical Capacity.

Atrial Fibrillation Clinical Trial

— LAAEX  

Official title:

Impact of Left Atrial Appendage Closure With a Closure Device on Quality of Life, Physical Capacity and Expression of Atrial Natriuretic Peptide and Brain Natriuretic

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03085693
• Other study ID #: SMW06
• Status: Active, not recruiting
• Start date: August 2016
• Est. completion date: November 2023

Study information

• Verified date: October 2022
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- It is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or Quality of life.

Description:

The monocentric trial deals with the endocrinological changes as a result of closure of the left atrial appendage with a internal closure device. Specially, the changes in atrial natriuretic peptide, brain natriuretic peptide and their impact on exercise capacity is on focus of the trial. The trial is planned as a all comers trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with a indication for LAA closure device Implantation

Exclusion Criteria:

• Inability to perform exercise testing

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	University of Jena	Jena

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity measured by maximal oxygen consumption	Change from baseline spiroergometry to 45 days to 6 months	Baselina, 45 days, 6 months