Atrial FibrillationNCT03085667
Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
An observational study of Atrial Fibrillation, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing left atrial appendage closure
Who may be able to join
- patients undergoing LAA closure
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Left atrial appendage occluder, Watchman device, Atrial fibrillation, atrial natriureitc peptide, brain natriuretic peptide
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline atrial natriuretic Peptide (ANP)
comparison of ANP level pre and post intervention
Measured: 24 h post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startJan 2011
- Primary completionJan 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Möbius-Winkler, University of Leipzig
- Investigators
- Sven Möbius-Winkler, MD, PhD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085667
- Sponsor's protocol ID
- SMW 05
- Status last verified
- Mar 2020
- First submitted
- 25 Oct 2016
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
- ClinicalTrials.gov ID
- NCT03085667
- Acronym / sponsor ID
- SMW 05
- Conditions
- Atrial Fibrillation
- Keywords
- Left atrial appendage occluder, Watchman device, Atrial fibrillation, atrial natriureitc peptide, brain natriuretic peptide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing left atrial appendage closure
Key inclusion criteria (1 listed)
- patients undergoing LAA closure
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline atrial natriuretic Peptide (ANP)
Time frame: 24 h post intervention
comparison of ANP level pre and post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Möbius-Winkler, MD, PhD principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline atrial natriuretic Peptide (ANP) (time frame: 24 h post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.