Impact of Left Atrial Appendage Closure on Physical Capacity.

Active, not recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT03085693
• Lead Sponsor: University of Leipzig

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2022-12
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient with a indication for LAA closure device Implantation

Exclusion Criteria

• Inability to perform exercise testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
exercise capacity measured by maximal oxygen consumption	Baselina, 45 days, 6 months	Change from baseline spiroergometry to 45 days to 6 months

Trial Locations

Locations (1)

University of Jena; 🇩🇪 Jena, Germany