NCT03085693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6.3 years

First QC Date

October 25, 2016

Last Update Submit

October 31, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • exercise capacity measured by maximal oxygen consumption

    Change from baseline spiroergometry to 45 days to 6 months

    Baselina, 45 days, 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients before and after closure of the left atrial appendage

You may qualify if:

  • Patient with a indication for LAA closure device Implantation

You may not qualify if:

  • Inability to perform exercise testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jena

Jena, 07747, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sven Möbius-Winkler, MD, PhD

    University of Jena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

October 25, 2016

First Posted

March 21, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2022

Study Completion

November 1, 2023

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)