- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085667
Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
March 4, 2020 updated by: Sven Möbius-Winkler, University of Leipzig
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.
Study Overview
Status
Completed
Conditions
Detailed Description
ANB and BNP levels are measured before, directly after and late after 24 h in central or periphereal venous blood from patients undergoing interventional LAA closure.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leipzig, Germany, 04289
- Heart Center Leipzig- University Leipzig
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive patients undergoing left atrial appendage closure
Description
Inclusion Criteria:
- patients undergoing LAA closure
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline atrial natriuretic Peptide (ANP)
Time Frame: 24 h post intervention
|
comparison of ANP level pre and post intervention
|
24 h post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sven Möbius-Winkler, MD, PhD, University of Leipzig
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
October 25, 2016
First Submitted That Met QC Criteria
March 14, 2017
First Posted (Actual)
March 21, 2017
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMW 05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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