NCT03085667

Brief Summary

Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in patients with Atrail fibrillation. Nothing is known about the acute influence of a device closure of the LAA on the secretion of ANB nad BNP hormones. Therefore aim of our study is to measure ANB and BNP levvels before and after Implantation of an LAA closure device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 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
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

October 25, 2016

Last Update Submit

March 4, 2020

Conditions

Atrial Fibrillation

Keywords

Left atrial appendage occluderWatchman deviceAtrial fibrillationatrial natriureitc peptidebrain natriuretic peptide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline atrial natriuretic Peptide (ANP)

    comparison of ANP level pre and post intervention

    24 h post intervention

Eligibility Criteria

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

Consecutive patients undergoing left atrial appendage closure

You may qualify if:

  • patients undergoing LAA closure

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center Leipzig- University Leipzig

Leipzig, 04289, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

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 Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 25, 2016

First Posted

March 21, 2017

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)